NCT04066881CompletedPhase 2
A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP
A Phase IIb Three-arm, Two-stage HIV Prophylactic Vaccine Trial With a Second Randomisation to Compare TAF/FTC to TDF/FTC as Pre-exposure Prophylaxis
Source: ClinicalTrials.gov · Last updated 22 Jan 2025
Brief summary (registry, in English)
This international, multi-centre, double-blind vaccine study is a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens i.e. DNA/AIDSVAX (weeks 0,4,24,48) and DNA/CN54gp140 (weeks 0,4) + MVA/CN54gp140 (weeks 24,48) with placebo control. There will be a concurrent open-label 1:1 randomisation to compare daily TAF/FTC (week 0-26) to daily TDF/FTC (weeks 0-26) as pre-exposure prophylaxis. The study aims to randomise up to 1668 eligible adults (18-40 years) through collaborating clinical research centres in 4 countries (Mozambique; South Africa; Tanzania; and Uganda). Each participant will be followed for a minimum of 74 weeks after enrolment. The trial is designed to detect a reduction in HIV incidence that has public health relevance sufficient to justify implementation of the combination vaccine regimen. In light of the high level of effectiveness demonstrated in the PrEP trials (up to 86% reduction in HIV), this trial is powered to detect a protective vaccine efficacy of 70% at the final analysis. The PrEP component will determine whether the effectiveness of TAF/FTC is unacceptably lower than the effectiveness of TDF/FTC.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 1512 (actual)
- First submitted
- 8 Aug 2019
- Start date
- 15 Dec 2020
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
- Diseases
- HIV
- NCT number
- NCT04066881
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 1512
- From 15 Dec 2020 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participating in another biomedical research study or in receipt of a live vaccine within 30 days prior to randomisation
- Participation in a previous HIV vaccine or HIV immunotherapy trial
- Receiving blood products or immunoglobulins within 12 weeks of screening
Other illness
- HIV infection or indeterminate HIV result at screening or enrolment
- Hepatitis B surface antigen positive
- Known hypersensitivity to any component of the vaccine formulations used in this trial or history of severe or multiple allergies to vaccines, drugs or pharmaceutical agents
- Presence of a systemic disease at the time of randomisation or history of chronic illness that in the opinion of the investigator may compromise the participant's safety, preclude vaccination or compromise an immune response to vaccine
Lab values
- If female, currently pregnant (evidence from positive serum or urine pregnancy test), or lactating
- Abnormalities in routine laboratory parameters (Hb, creatinine, AST/ALT, alkaline phosphatase, total Bilirubin and glucose) of Grade 2 and above using the DAIDS toxicity table, version 2.1 July 2017 or estimated glomerular filtration rate less than 50ml/min
Who the study is looking for
- HIV uninfected adults aged between 18 and 40 years old on the day of screening
- Willing and able to provide informed consent prior to participation
- Willing and able to comply with the visit schedule and provide blood, urine and other samples at the required time points
- Home address accessible for visiting and intending to remain within the recruitment area for at least 82 weeks from screening
- Likely to be at risk from exposure to HIV during follow up
- Willing to undergo HIV testing, receive HIV test results and risk reduction counselling which includes promotion of PrEP and condoms
- If female, of child-bearing age and not sterilised, willing to use a highly effective method of contraception from screening until 18 weeks after the last injection
- If male and not sterilised, willing to avoid impregnating female partners from screening until 18 weeks after the last injection
Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MRC/UVRI and LSHTM Uganda Research Unit Coordinator of this site? Confirm its status | Entebbe | Uganda | Unknown status |
Related publications
- Nurse counselors' experiences of recruitment and retention of female sex workers in a HIV vaccine trial: a qualitative study from urban Tanzania.Trials · 2026 · PMID 42410635
- A Comparison of F/TAF and F/TDF as HIV Pre-Exposure Prophylaxis in a Predominantly Cisgender Women Population in East and South Africa: A Randomized, Factorial, Noninferiority Trial.J Acquir Immune Defic Syndr · 2026 · PMID 41650395
- Understanding trial designs and acceptability of participation in an HIV vaccine trial with concurrent randomisation to oral pre-exposure prophylaxis in East and Southern Africa: a longitudinal qualitative study.Trials · 2026 · PMID 42141483
- The experience of trial participation disclosure among sex workers in a phase IIb HIV vaccine trial: A qualitative study in urban Tanzania.PLOS Glob Public Health · 2025 · PMID 41259346
This page is information, not medical advice. Discuss any trial with your doctor.