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SNCTP000003751 | NCT02716675 | BASEC2016-01558

HVTN704/HPTN085 - Etude de phase 2b visant à évaluer l’innocuité et l’efficacité de l’anticorps neutralisant à large spectre VRC01 dans la réduction du risque d’infection VIH-1 chez les hommes cisgenres et les personnes transgenres ayant des rapports sexuels avec des hommes

Data source: BASEC (Imported from 07.05.2021), WHO (Imported from 18.04.2021)
Changed: 04.05.2021
Disease category: Infections and Infestations

Brief description of trial (Data source: BASEC)

Il s'agit d'une étude clinique pilotée par le HIV Vaccine Trials Network (HVTN) et le HIV Prevention Trials Network (HPTN) visant à évaluer l'innocuité et l'efficacité de l'anticorps neutralisant VRC01 dans la réduction du risque d'infection VIH-1 chez les hommes cisgenres et les personnes transgenres qui ont des rapports sexuels avec des hommes ou des personnes transgenres.

2700 volontaires en bonne santé, non infecté-e-s par le VIH et âgé-e-s entre 18 et 50 ans, seront enrôlé-e-s au Centre d’Immunothérapie et de Vaccinologie (VIC) du CHUV et dans différents sites cliniques aux Etat-Unis, au Pérou et au Brésil.

Pour chaque participant-e, l’étude s’étendra sur environ 21 mois (92 semaines) et comprend 26 visites cliniques. Les participant-e-s de l’étude seront réparti-e-s de manière aléatoire dans 3 groupes pour recevoir 10 perfusions intraveineuses (une toutes les 8 semaines):
- d'anticorps VRC01 à une dose de 10 mg/kg ou
- d'anticorps VRC01 à une dose de 30 mg/kg ou
- d'une solution saline 0.9% (placebo).

Les volontaires prendront note de leur état de santé le soir même de la perfusion ainsi que les 3 jours suivants. Entre chaque visite de perfusion, des visites de suivi avec prises de sang, test VIH et conseils seront effectuées ainsi que toutes les 4 semaines depuis la dernière perfusion (semaine 72) jusqu'à la dernière visite de l'étude (semaine 92).

Health conditions investigated (Data source: BASEC)

Infections VIH

Health conditions (Data source: WHO)

HIV Infections

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Perfusion de l’anticorps neutralisant à large spectre VRC01 à une dose de 10 mg/kg ou 30 mg/kg ou d'un placebo (solution saline 0.9%).

Interventions (Data source: WHO)

Biological: VRC01;Biological: Placebo for VRC01

Criteria for participation in trial (Data source: BASEC)

-Hommes cisgenres ou personnes transgenres qui, dans les 6 mois précédant la randomisation, ont rempli au moins un des critères de risque VIH suivants:
-relations sexuelles anales sans préservatif avec 1 ou plusieurs hommes cisgenres ou personnes transgenres
- relations sexuelles anales avec 2 ou plusieurs hommes cisgenres ou personnes transgenres

-Agé-e-s de 18 à 50 ans
-Bonne santé générale comme indiqué par les antécédents médicaux, l'examen médical et les tests de laboratoire du screening.
-Non infecté-e-s par le VIH
-Possibilité et volonté de fournir un consentement éclairé

Exclusion criteria (Data source: BASEC)

-Tout test VIH réactif, indéterminé ou séropositif.
-Vaccin expérimental VIH reçu dans un essai préalable.
-Réaction indésirable grave aux composants de la formulation du VRC01
-Problème médical significatif, résultats de laboratoire anormaux, ou antécédents médicaux avec des conséquences significatives sur la santé actuelle.

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

General and Demographic Criteria

- Age of 18 to 50 years

- Access to a participating clinical research site (CRS) and willingness to be followed
for the planned duration of the study

- Ability and willingness to provide informed consent

- Assessment of understanding: volunteer demonstrates understanding of this study and
completes a questionnaire prior to first infusion with verbal demonstration of
understanding of all questionnaire items answered incorrectly

- Agrees not to enroll in another study of an investigational research agent for the
duration of the participant's trial participation

- Good general health as shown by medical history, physical exam, and screening
laboratory tests

HIV-Related Criteria

- Willingness to receive HIV test results

- Willingness to discuss HIV infection risks and amenable to HIV risk reduction
counseling

- Persons born Male or identifying as Transgender (TG) (male-to-female or
female-to-male, see HVTN 704/HPTN 085 SSP) who, in the 6 months prior to
randomization, experienced 1 or both of the following HIV risk criteria:

- Condomless anal intercourse with 1 or more male or transgender partner(s)

- Anal intercourse with 2 or more male or transgender partners

- Male-to-female and female-to-male TG volunteers are eligible. Receipt of hormonal
therapy does not make a TG volunteer ineligible.

- Volunteers who have been in a mutually monogamous relationship with an HIV-1
seronegative partner for greater than 1 year are excluded.

Laboratory Inclusion Values:

Hematology

- Hemoglobin (Hgb) greater than or equal to 10.5 g/dL for volunteers who were born
female, greater than or equal to 13.0 g/dL for volunteers who were born male (greater
than or equal to 12.0 g/dL for transgender women taking feminizing hormones [e.g.,
anti-androgens, estrogens])

- Platelets greater than or equal to 100,000 cells/mm^3

Chemistry

- Alanine aminotransferase (ALT) less than 2.5 times the institutional upper limit of
normal and creatinine less than or equal to 1.25 times the institutional upper limit
of normal

Virology

- HIV uninfected, as defined in the SSP, within 30 days prior to enrollment

Urine

- Negative, trace, or 1+ (30 g/L for semi-quantitative) urine protein by dipstick

Reproductive Status

- Volunteers capable of becoming pregnant: negative serum or urine beta human chorionic
gonadotropin (ß-HCG) pregnancy test performed at the screening visit and prior to
infusion on the day of initial infusion. Persons who are NOT capable of becoming
pregnant due to having undergone total hysterectomy or bilateral oophorectomy
(verified by medical records) are not required to undergo pregnancy testing.

- Reproductive Status: A volunteer who is capable of becoming pregnant must agree to
consistently use effective contraception (see the protocol and SSP for more
information) for sexual activity that could lead to pregnancy from at least 21 days
prior to enrollment through the last required protocol clinic visit.

- Volunteers capable of becoming pregnant must also agree not to seek pregnancy through
alternative methods, such as artificial insemination or in vitro fertilization until
after the last required protocol clinic visit

Exclusion Criteria:

General

- Investigational research agents received within 30 days before first infusion

- Body mass index (BMI) greater than or equal to 40

- Pregnant or breastfeeding

- Any reactive, indeterminate, or positive HIV test, even if subsequent testing
indicates that the individual is not HIV infected, except as permitted by the HVTN
704/HPTN 085 Protocol Safety Review Team (PSRT).

Vaccines

- HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received
control/placebo in an HIV vaccine trial, the HVTN 704/HPTN 085 PSRT will determine
eligibility on a case-by-case basis.

Immune System

- Serious adverse reactions to VRC01 formulation components such as sodium citrate,
sodium chloride, and L-arginine hydrochloride, including history of anaphylaxis and
related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal
pain.

- Autoimmune disease, including Type I diabetes mellitus (Not excluded from
participation: Volunteer with mild, stable and uncomplicated autoimmune disease that
does not require consistent immunosuppressive medication and that, in the judgment of
the site investigator, is likely not subject to exacerbation and likely not to
complicate reactogenicity and AE assessments)

- Immunodeficiency syndrome

Clinically Significant Medical Conditions

- Clinically significant medical condition, physical examination findings, clinically
significant abnormal laboratory results, or past medical history with clinically
significant implications for current health. A clinically significant condition or
process includes but is not limited to:

- Any contraindication to repeated infusions or blood draws, including inability to
establish venous access;

- A condition that requires active medical intervention or monitoring to avert
grave danger to the volunteer's health or well-being during the study period; or

- A condition or process for which signs or symptoms could be confused with
reactions to VRC01.

- Any medical, psychiatric, occupational, or other condition that, in the judgment of
the investigator, would interfere with, or serve as a contraindication to, protocol
adherence, assessment of safety or infusion reactions, or a volunteer's ability to
give informed consent

- Psychiatric condition that precludes compliance with the protocol. Specifically
excluded are persons with psychoses within the past 3 years, ongoing risk for suicide,
or history of suicide attempt or gesture within the past 3 years.

- Asthma, other than mild, well-controlled asthma

- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or
platelet disorder requiring special precautions)

- Malignancy (Not excluded from participation: Volunteer who has had malignancy excised
surgically and who, in the investigator's estimation, has a reasonable assurance of
sustained cure, or who is unlikely to experience recurrence of malignancy during

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02716675

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02716675

Further information on trial

Date trial registered

17.03.2016

Incorporation of the first participant

06.04.2016

Recruitment status

Completed

Academic title (Data source: WHO)

A Phase 2b Study to Evaluate the Safety and Efficacy of VRC01 Broadly Neutralizing Monoclonal Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).

Phase (Data source: WHO)

Phase 2

Primary end point (Data source: WHO)

Number of participants with local and systemic reactogenicity signs and symptoms;Number of participants with adverse events (AEs);Number of participants with severe adverse events (SAEs);Rates of participant discontinuation from the study;Documented HIV-1 infection by the Week 80 study visit

Secundary end point (Data source: WHO)

Serum concentration of VRC01 in participants assigned to receive the mAb (ELISA, neutralizing assay);Serum mAb effector functions to HIV-1 Envs representing variability of the VRC01 antibody footprint;Sequences of breakthrough HIV infections from the earliest available HIV-positive plasma samples;VRC01 neutralization-sensitivity of, and effector function against, HIV strains from infected trial participants from the earliest available post-HIV-infection serum samples

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Lausanne

Countries (Data source: WHO)

Brazil, Peru, Switzerland, United States

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Sandra Bettinelli Riccardi
+41 21 314 92 82
Sandra.Bettinelli-Riccardi@chuv.ch

Contact for general information (Data source: WHO)

Lawrence Corey;Myron Cohen
HVTN; FHCRC;HPTN; University of North Carolina

Contact for scientific information (Data source: WHO)

Lawrence Corey;Myron Cohen
HVTN; FHCRC;HPTN; University of North Carolina

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

National Institute of Allergy and Infectious Diseases (NIAID)

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Commission cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)

Date of authorisation by the ethics committee

02.11.2016

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2016-01558

Secondary ID (Data source: WHO)

30095
HVTN 704/HPTN 085