Status:
COMPLETED
A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP
Lead Sponsor:
MRC/UVRI and LSHTM Uganda Research Unit
Collaborating Sponsors:
Imperial College London
University College, London
Conditions:
HIV Infections
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief 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,...
Detailed Description
This international, multi-centre, double-blind vaccine study will be a three-arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens with placebo control. ...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Exclusion
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
1512 Patients enrolled
Trial Details
Trial ID
NCT04066881
Start Date
December 15 2020
End Date
December 31 2024
Last Update
January 22 2025
Active Locations (1)
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1
MRC/UVRI and LSHTM Uganda Research Unit
Entebbe, Uganda