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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-035-19

Enrollment

600

Registered

2020-01-29

Start date

2020-03-01

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1: Ad26.Mos4.HIV,Clade C and Mosaic gp140 bivalent vaccine Type of group

Participants will receive adenovirus serotype 26.Mosaic 4.human immunodeficiency virus (Ad26.Mos4.HIV) via intramuscular (IM) injection into the deltoid muscle at months 0 (Day 1) and 3 (preferably the deltoid of the non-dominant upper arm) and, Ad26.Mos4.HIV together with Clade C and Mosaic gp140 HIV bivalent vaccine IM into the deltoid muscle at Months 6 and 12 (different deltoid for each injection). Group name:Group 2: Placebo Type of group

Placebo Comparator: Participants will receive placebo via intramuscular (IM) injection into the deltoid muscle on Months 0 (Day 1), 3 (1 injection), 6 and 12 (2 injections).

Eligibility

Inclusion criteria

Inclusion criteria: - 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 or gender non-conforming individual having receptive anal and/or vaginal condom-less intercourse and who is considered by the site staff to be at increased risk for HIV-1 infection. The potential participants must in the last 6 months have had any condom-less receptive anal or vaginal sex (not included is condom-less 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 (example, cocaine, amphetamine) or 5 or more sex partners. - Potential participant is negative for HIV-1 and HIV-2 infection less than (<) 28 days prior to first vaccination. - Potential participant must be healthy based on medical history, physical examination, and vital sign measurement performed at screening. - 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. - All participants of childbearing potential must have a negative highly sensitive urine or serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration.

Exclusion criteria

Exclusion criteria: - Potential participants choosing to use PrEP. However, once participants received the first vaccination, they will be allowed to start PrEP while in the study according to the site PrEP plan. The use of long acting PrEP is disallowed from 24 months prior to Day 1. - 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. - 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 - Potential participant has known allergy or history of anaphylaxis or other serious adverse reactions to vaccines. - 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.

Design outcomes

Primary

Measure	Time frame
Outcome name:Vaccine efficacy is defined as 1-cumulative incidence ratio (vaccine versus placebo) between Month 7 and Month X after first vaccination and is estimated by the transformation of the Nelson-Aalen estimator for the cumulative hazard function after enrollment in the per-protocol (PP) population. Here, month X will be between month 24 and month 30. Measure:Vaccine Efficacy (VE) as Derived From Confirmed HIV-1 Infections Diagnosed Between the Month 7 and Month X (with 24 Less Than or Equal to [<=] X <= 30) Visits. Timepoints:From Month 7 up to Month 30	—

Measure

Time frame

Outcome name:Vaccine efficacy is defined as 1-cumulative incidence ratio (vaccine versus placebo) between Month 7 and Month X after first vaccination and is estimated by the transformation of the Nelson-Aalen estimator for the cumulative hazard function after enrollment in the per-protocol (PP) population. Here, month X will be between month 24 and month 30. Measure:Vaccine Efficacy (VE) as Derived From Confirmed HIV-1 Infections Diagnosed Between the Month 7 and Month X (with 24 Less Than or Equal to [<=] X <= 30) Visits. Timepoints:From Month 7 up to Month 30

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Secondary

Measure	Time frame
Outcome name:Number of participants with local solicited adverse events will be evaluated. An adverse event is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention, therefore it can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Solicited local AEs include assessment of pain/tenderness, erythema and swelling. Solicited systemic AEs: fatigue, headache, nausea, myalgia, chills, arthralgia, and vomiting will be assessed. Measure:Number of Participants with Solicited Local and Systemic Adverse Events (AEs) Timepoints:7 days after each vaccination on Months 0, 3, 6, and 12 ; Outcome name:Number of Participants with unsolicited AEs will be evaluated. Unsolicited adverse events are all adverse events for which the participant is specifically not questioned in the participant diary. Measure:Number of Participants with Unsolicited Adverse Events Timepoints:28 days after each vaccination on Months 0, 3, 6, and 12 ; Outcome name:Number of participants with MAAEs will be evaluated. MAAEs are defined as adverse events with medically attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Measure:Number of Participants with Medically-attended adverse events (MAAEs) Timepoints:Up to 43 Months (participants will be followed until the last participant reaches Month 30) ; Outcome name:Number of participants with SAE will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, i	—

Measure

Time frame

Outcome name:Number of participants with local solicited adverse events will be evaluated. An adverse event is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention, therefore it can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Solicited local AEs include assessment of pain/tenderness, erythema and swelling. Solicited systemic AEs: fatigue, headache, nausea, myalgia, chills, arthralgia, and vomiting will be assessed. Measure:Number of Participants with Solicited Local and Systemic Adverse Events (AEs) Timepoints:7 days after each vaccination on Months 0, 3, 6, and 12 ; Outcome name:Number of Participants with unsolicited AEs will be evaluated. Unsolicited adverse events are all adverse events for which the participant is specifically not questioned in the participant diary. Measure:Number of Participants with Unsolicited Adverse Events Timepoints:28 days after each vaccination on Months 0, 3, 6, and 12 ; Outcome name:Number of participants with MAAEs will be evaluated. MAAEs are defined as adverse events with medically attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Measure:Number of Participants with Medically-attended adverse events (MAAEs) Timepoints:Up to 43 Months (participants will be followed until the last participant reaches Month 30) ; Outcome name:Number of participants with SAE will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, i

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Countries

Argentina, Brazil, Italy, Mexico, Peru, Poland, Spain, United States

Contacts

Public ContactClaudia Zamata

IQVIA RDS Peru S.R.L

claudia.zamata@iqvia.com3380596

Outcome results