A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccin… (NCT04066881) | Clinical Trial Compass
CompletedPhase 2
A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP
Uganda1,512 participantsStarted 2020-12-15
Plain-language summary
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.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
What they're measuring
1
Incident HIV infection
Timeframe: after week 26
2
Incident HIV infection
Timeframe: week 0-26
3
A clinical decision to discontinue the vaccine regimen for an adverse event that is considered related to product
Timeframe: week 0-48
4
A clinical decision to discontinue PrEP regimen for an adverse event that is considered related to product
. HIV infection or indeterminate HIV result at screening or enrolment
✕. Hepatitis B surface antigen positive
✕. If female, currently pregnant (evidence from positive serum or urine pregnancy test), or lactating
✕. 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
✕. 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