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    Summary
    EudraCT Number:2018-003666-13
    Sponsor's Protocol Code Number:VAC89220HPX3002
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-003666-13
    A.3Full title of the trial
    A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of a Heterologous Vaccine Regimen of Ad26.Mos4.HIV and Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals who Have Sex with Cis-gender Men and/or Transgender Individuals.
    Uno studio di efficacia di fase 3 multicentrico, randomizzato, in doppio cieco, controllato con placebo su un regime vaccinale eterologo composto da Ad26.Mos4.HIV e un’associazione di gp140 Clade C e mosaico gp140 con adiuvante per prevenire l’infezione da HIV-1 in maschi cis-gender e individui transgender che hanno rapporti sessuali con maschi cis-gender e/o individui transgender.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the effectiveness of a vaccine regimen consisting of Ad26.Mos4.HIV and a combination of adjuvanted Clade C gp140 and Mosaic gp140 to prevent HIV-1 infection among cis-gender men and transgender individuals who have sex with cis-gender men and/or transgender individuals
    Uno studio clinico per valutare l'efficacia di un regime vaccinale eterologo composto da Ad26.Mos4.HIV e un’associazione di gp140 Clade C e mosaico gp140 con adiuvante per prevenire l’infezione da HIV-1 in maschi cis-gender e individui transgender che hanno rapporti sessuali con maschi cis-gender e/o individui transgender.
    A.3.2Name or abbreviated title of the trial where available
    MOSAICO
    MOSAICO
    A.4.1Sponsor's protocol code numberVAC89220HPX3002
    A.5.4Other Identifiers
    Name:HVTNNumber:HVTN 706
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Vaccines & Prevention B.V.
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Vaccines & Prevention B.V.
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportNational Institute of Allergy and Infectious Diseases
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportJANSSEN CILAG SPA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Research & Development
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 20
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAd26.Mos4.HIV
    D.3.2Product code [Ad26.Mos4.HIV]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAd26.Mos4.HIV
    D.3.9.4EV Substance CodeSUB197455
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms/ml billion organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAdjuvanted Clade C and Mosaic gp140 HIV Bivalent Vaccine, Recombinant
    D.3.2Product code [JNJ-65184340]
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeJNJ-55471585
    D.3.9.4EV Substance CodeSUB197456
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeJNJ-64219311
    D.3.9.4EV Substance CodeSUB197457
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of HIV-1 Infection
    Prevenzione infezione HIV
    E.1.1.1Medical condition in easily understood language
    Prevention of HIV-1 Infection
    Prevenzione infezione HIV
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the vaccine efficacy (VE) of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.
    Valutare l’efficacia vaccinale (EV) di un regime vaccinale eterologo che utilizza Ad26.Mos4.HIV e un’associazione di gp140 Clade C e gp140 mosaico con fosfato di alluminio quale adiuvante per la prevenzione dell’infezione da HIV-1 in maschi cis-gender e individui transgender sieronegativi all’HIV-1 che hanno rapporti sessuali con maschi cis-gender e/o individui transgender.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety and reactogenicity of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cis-gender men and/or transgender individuals.
    2. To evaluate VE at other timepoints and in other analysis populations.
    3. To evaluate the immune responses elicited by the vaccine regimen.
    4. To evaluate VE by and adjusting for potential (baseline) confounders.
    1. Valutare la sicurezza e la reattogenicità di un regime vaccinale eterologo che utilizza Ad26.Mos4.HIV e un’associazione di gp140 Clade C e gp140 mosaico con fosfato di alluminio quale adiuvante per la prevenzione dell’infezione da HIV-1 in maschi cis-gender e individui transgender sieronegativi all’HIV-1 che hanno rapporti sessuali con maschi cis-gender e/o individui transgender
    2. Valutare la EV in corrispondenza di altri timepoint e in diverse popolazioni di analisi
    3. Valutare le risposte immunitarie stimolate dal regime vaccinale
    4. Valutare la EV e adattandola a fattori confondenti (basali)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Potential participant is =18 to =60 years old on the day of signing the ICF.
    2.Individual is either:
    - Cis-gender man having sex with cis-gender men and/or transgender individuals, OR
    - Transgender woman having sex with cis-gender men and/or transgender individuals, OR
    - Transgender man having sex with cis-gender men and/or transgender women (transgender man having sex exclusively with transgender men
    is excluded), OR - Gender non-conforming individual having receptive or insertive anal and/or vaginal condomless intercourse, AND who is considered by the site staff to be at increased risk for HIV-1 infection.
    3.The potential participants must in the last 6 months have had:
    - Any condomless receptive anal or vaginal sex (not included is condomless anal sex within a mutually monogamous relationship =12 months if the partner is HIV negative or living with HIV and virally
    suppressed), OR
    - Rectal or urethral gonorrhea or chlamydia or incident syphilis, OR
    - Any stimulant use or any other drug and/or substance which in the local context may be associated with increased HIV transmission (eg, cocaine, amphetamine), OR
    - 5 or more sex partners
    4.Potential participant is negative for HIV-1 and HIV-2 infection <=28 days prior to first vaccination.
    5.Potential participant must be healthy based on medical history, physical examination, and vital sign measurement performed at screening.
    6.Contraceptive use by participants assigned female at birth and who have not had sexual reassignment surgery should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies.
    7.All participants of childbearing potential must:
    - Have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening
    - Have a negative urine ß-hCG pregnancy test immediately prior to each study vaccine administration
    1.Il potenziale partecipante deve avere un’età compresa tra =18 e =60 anni il giorno della firma dell’ICF.
    2.Il potenziale partecipante deve essere
    - un maschio cis-gender che ha rapporti sessuali con maschi cis-gender e/o individui transgender
    o -una transgender donna che ha rapporti sessuali con maschi cis-gender e/o individui transgender
    o -un transgender uomo che ha rapporti sessuali con maschi cis-gender e/o individui transgender donne (transgender uomini che hanno rapporti esclusivamente con transgender uomini sono esclusi)
    o -un individuo “gender non-conforming” che ha rapporti anali come ricevente o da attivo e/o vaginali senza profilattico e che, secondo il giudizio dello staff del centro di sperimentazione, è esposto a un aumentato rischio di infezione da HIV-1.
    3-I potenziali partecipanti devono aver avuto negli ultimi 6 mesi:
    -.sesso anale o vaginale come ricevente senza profilattico (non è incluso il sesso anale senza profilattico in una relazione mutualmente monogama per = di 12 mesi se il partner è HIV negativo o vive con l’HIV in soppressione virale)
    o -gonorrea o clamidia rettale o uretrale o sifilide incidente
    o-uso di qualsiasi stimolante o qualsiasi altra droga e/o sostanza che nel contesto locale può essere associata ad una maggiore trasmissione dell'HIV (esempio cocaina, anfetamina)
    o-5 o più partner sessuali.
    4.Il potenziale partecipante deve essere negativo all’infezione da HIV-1 e HIV-2 <=28 giorni prima della prima vaccinazione.
    5.Il potenziale partecipante deve essere sano in base all’anamnesi medica, all’esame obiettivo e alla misurazione dei segni vitali eseguita allo screening.
    6.Per i partecipanti assegnati al genere femminile alla nascita, che non hanno avuto una riassegnazione sessuale tramite la chirurgia, l’uso dei contraccettivi deve avvenire in conformità alle regolamentazioni locali esistenti in materia di metodi contraccettivi accettabili per i soggetti che partecipano a studi clinici.
    7.Tutti i partecipanti potenzialmente in grado di concepire una gravidanza devono:
    a.Presentare un test di gravidanza o sul siero (ß-gonadotropina corionica umana [ßhCG]) negativo allo screening
    b.Presentare un test di gravidanza ß-hCG sull’urina negativo subito prima di ogni somministrazione di vaccino dello studio
    E.4Principal exclusion criteria
    1.Potential participant shares needles during injection of drugs or any other substance.
    2.Potential participant has any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation.
    3.Potential participant received or plans to receive:
    - licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccination[s]
    - other licensed (not live) vaccines - within 14 days before or after planned administration of the first or subsequent study vaccination[s].
    4.Potential participants choosing to use PrEP. However, once participants are enrolled and received their first vaccination, and they change their mind regarding PrEP usage, they will be allowed to take PrEP according to the site PrEP plan and will continue to receive further vaccinations.
    5.Potential participant has used investigational research agents within 28 days of randomization.
    6.Potential participant is a recipient of a HIV-vaccine candidate at any time, or a recipient of other experimental vaccine(s) within the last 12 months prior to Day 1. For participants who received an experimental vaccine (except HIV vaccine) more than 12 months prior to Day 1, documentation of the identity of the experimental vaccine must be provided to the HPX3002/HVTN 706 safety review team, who will determine eligibility on a case-by-case basis.
    7.Potential participant has received an HIV-related mAb, whether licensed or investigational, within the last 12 months prior to Day 1. For participants who received an HIV-related mAb more than 12 months prior to Day 1, documentation of the identity of the mAb must be provided to the HPX3002/HVTN 706 safety review team, who will determine eligibility on a case-by-case basis.
    8.Potential participant has been in receipt of blood or Ig products in the past 3 months.
    9.Potential participant has known allergy or history of anaphylaxis or other serious adverse reactions to vaccines.
    10.Potential participant has a history of any chronic/recurrent conditions that require regular/recurrent use of oral/parenteral corticosteroids or other immunomodulators/immunosuppressors. Ocular, topical or inhaled steroids are allowed.
    11 Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study vaccination.
    1.Il potenziale partecipante che condivide gli aghi durante l’iniezione di farmaci o di qualsiasi altra sostanza.
    2.Il potenziale partecipante presenta qualsiasi condizione medica acuta o cronica clinicamente significativa che, secondo l’opinione dello sperimentatore, precluderebbe la partecipazione nello studio.
    3.Il potenziale partecipante ha ricevuto o prevede di ricevere:
    -vaccini attenuati vivi autorizzati - entro i 28 giorni precedenti o successivi alla somministrazione programmata della prima vaccinazione dello studio o delle vaccinazioni successive
    -altri vaccini autorizzati (non vivi) - entro i 14 giorni precedenti o successivi alla somministrazione programmata della prima vaccinazione dello studio o delle vaccinazioni successive
    4.I potenziali partecipanti che scelgono di utilizzare la PrEP. Una volta arruolati e ricevuta la prima vaccinazione, e cambiata idea sull’uso della PrEP, i partecipanti potranno utilizzare la PrEP secondo il piano di prescrizione del centro e continueranno a ricevere le successive vaccinazioni.
    5.l potenziale partecipante ha utilizzato prodotti sperimentali entro i 28 giorni precedenti alla randomizzazione.
    6.Il potenziale partecipante è candidato a ricevere un vaccino contro l’HIV in qualsiasi momento o ha ricevuto uno o più vaccini sperimentali di altro tipo entro i 12 mesi precedenti al Giorno 1. Per i partecipanti che hanno ricevuto un vaccino sperimentale (tranne il vaccino per l’HIV) oltre 12 mesi prima del Giorno 1, occorre fornire la documentazione relativa al vaccino sperimentale al team incaricato di valutare i dati di sicurezza dello studio HPX3002/HVTN 706, il quale stabilirà l’idoneità caso per caso.
    7.Il potenziale partecipante ha ricevuto un mAb correlato all’HIV, autorizzato o sperimentale, entro i 12 mesi precedenti al Giorno 1. Per i partecipanti che hanno ricevuto un mAb correlato all’HIV oltre 12 mesi prima del Giorno 1, occorre fornire la documentazione relativa al mAb al team incaricato di valutare i dati di sicurezza dello studio HPX3002/HVTN 706, il quale stabilirà l’idoneità caso per caso.
    8.Il potenziale partecipante ha ricevuto sangue o Immunoglobuline nei 3 mesi precedenti.
    9.Il potenziale partecipante presenta un’allergia nota o una storia di anafilassi o altre reazioni avverse serie ai vaccini.
    10.Il potenziale partecipante presenta una storia di condizioni croniche o ricorrenti che richiedono l’utilizzo regolare o ricorrente di corticosteroidi o altri immunomodulatori o immunosoppressori per via orale o parenterale. Gli steroidi con somministrazione orale, topica o inalatoria sono consentiti.
    11.Il potenziale partecipante è in gravidanza o allatta al seno oppure intende iniziare una gravidanza durante l’arruolamento nello studio o entro i 90 giorni successivi l’ultima dose di vaccinazione dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed HIV-1 infections diagnosed between Month 7 and Month x (with 24=x=30) visits in the per-protocol (PP) population.
    Infezioni confermate da HIV-1 diagnosticate tra le visite del Mese 7 e del Mese x (con 24=x=30) nella popolazione per-protocol (PP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Months 7 to 30
    dal mese 7 al 30
    E.5.2Secondary end point(s)
    a) Reactogenicity: Solicited administration site and systemic adverse events for 7 days after each vaccination
    b) Unsolicited adverse events for 28 days after each vaccination
    c) Medically-attended adverse events (MAAEs) for the entire duration of the study
    d) Serious adverse events for the entire duration of the study
    e) Discontinuations from the study or vaccination due to adverse events; Confirmed HIV-1 infections over different time intervals (eg, VE[0-x months], VE[13-x months]) and in different populations (eg, modified intent-to-treat [mITT], mITT-2, full immunization set [FIS]); The frequency and magnitude of HIV-1 envelope (Env)-specific cellular and humoral immune responses in the PP population, determined by Clade C gp140 and Mos1 gp140 specific enzyme-linked immunosorbent assay (ELISA) and clinical potential T cell epitopes (cPTE) Env peptide enzyme-linked immunospot (ELISpot).; Potential confounders include but are not limited to: demographic characteristics, baseline Ad26 seropositivity status and titer, sexual risk behavior, and pre-exposure prophylaxis (PrEP) use.
    a) Reattogenicità: eventi avversi, al sito di somministrazione e sistemici, riferiti a seguito di domande mirate da parte del medico dello studio nei 7 giorni successivi a ogni vaccinazione
    b) Eventi avversi riportati spontaneamente nei 28 giorni successivi ad ogni vaccinazione
    c) Eventi avversi curati da un operatore sanitario (MAAEs) occorsi durante l’intera durata dello studio
    d) Eventi avversi seri per l’intera durata dello studio
    e) Interruzioni dello studio o della vaccinazione a causa di eventi avversi; Infezioni confermate da HIV-1 in diversi intervalli di tempo (ad es., EV [0-x mesi], EV [13-x mesi]) e in diverse popolazioni [ad es., popolazione intent-to-treat modificata (mITT), mITT-2, set di immunizzazione completo (Full Immunization Set, FIS)]; Frequenza ed entità delle risposte immunitarie cellulari e umorali specifiche alle proteine tradotte dal gene Env dell’HIV-1 nella popolazione PP. Questi valori saranno determinati con la metodica ELISA (Enzyme-Linked Immunosorbent Assay) e la metodica ELISpot (Enzyme-Linked Immunospot) con stimolazione con il peptide Env cPTE (potenziali epitopi clinici di linfociti T) specifiche per gp140 Clade C e gp140 Mos1.; I potenziali fattori confondenti comprendono, a titolo esemplificativo: caratteristiche demografiche, titolo e stato di sieropositività Ad26 basale, comportamento associato ai rischi sessuali e utilizzo della profilassi pre-esposizione (PrEP).
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) 7 days after each vaccination
    b) 28 days after each vaccination
    c), d) & e) Throughout the duration of the study; Months 0, 3, 6, 7, 9, 12, 13, 15, 18, 21, 24, 27 and 30, every 3 months post Month 30 follow-up visit and exit visit; Months 0, 7, 13, 18, 24 and 30, and exit visit; Throughout the duration of the study
    a) 7 giorni dopo ogni vaccinazione
    b) 28 giorni dopo ogni vaccinazione
    c), d) & e) per tutta la durata dello studio; Mesi 0, 3, 6, 7, 9, 12, 13, 15, 18, 21, 24, 27 and 30, ogni 3 mesi dopo il mese 30, alla visita di fu e alla visita di uscita dallo studio; Mesi 0, 7, 13, 18, 24 and 30, e visita uscita dallo studio; per tutta la durata dello studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Reactogenicity, Immunogenicity, Patient reported outcomes
    Reattogenicità, immunogenicità, outcomes riportati dal paziente
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Mexico
    Peru
    United States
    Italy
    Poland
    Spain
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLP: last patient last visit
    LVLP (ultima visita dell'ultimo paziente)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 3800
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 3800
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation HIV Vaccine Trials Network
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-12
    P. End of Trial
    P.End of Trial StatusOngoing
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