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AIDSVAX® B/E Program: Clinical Trials

The following table represents the extensive clinical history of AIDSVAX®
B/E and the current studies where GSID serves as a manufacturing and product sponsor:

Study Protocol
Phase
Study Location
Clinical Trial Sponsor
Priming Vaccine
Study Status
VAX001
1/2
Thailand
VaxGen
AIDSVAX® B/E alone
Completed
VAX002
1/2
US
VaxGen
AIDSVAX® B/E alone
Completed
VAX003
3
Thailand
Bangkok Metropolitan Authority, Mahidol University and VaxGen
AIDSVAX® B/E alone
Completed
RV 135
1/2
Thailand
US Surgeon General / Dept. of the Army / WRAIR
Sanofi Pasteur ALVAC VCP1521
Completed
RV 144
3
Thailand
US Surgeon General / Dept. of the Army, NIH / NIAID, Thai MOPH, Mahidol University and the Royal Thai Army
Sanofi Pasteur ALVAC vCP1521
Completed

Study Protocol
Phase
Study Location
Clinical Trial Sponsor
Priming Vaccine
Study Status
RV305
2
Thailand
US Surgeon General / Dept. of the Army
Sanofi Pasteur ALVAC vCP1521
Completed
RV305A
2
Thailand
US Surgeon General / Dept. of the Army
AIDSVAX B/E boost only
Completed
RV306
2
Thailand
US Surgeon General / Dept. of the Army
Sanofi Pasteur ALVAC vCP1521
Completed
RV328
2
Thailand
US Surgeon General / Dept. of the Army
None / AIDSVAX B/E alone
Completed
HVTN 096/EV04
1
Switzerland
EuroVacc Foundation
EuroVacc NYVAC HIV-PT1, NYVAC HIV-PT4, IPPOX DNA-HIV-PT123
Completed*
HVTN097
1b
Republic of South Africa
NIH / NIAID / DAIDS
Sanofi Pasteur ALVAC vCP 1521
Completed*
HVTN105
1b
USA
NIH / NIAID / DAIDS
IPPOX DNA-HIV-PT123
Completed*
HVTN110
1
USA
PaxVax Inc.
PaxVax Ad4 mgag/Env C150
Completed
HVTN114
1
USA / Peru
NIH / NIAID / DAIDS
GeoVax MVA / HIV62B
Completed
HVTN121
1
USA
NIH / NIAID / DAIDS
AIDSVAX B/E alone
Completed
PXVX-HIV-100-001
1b
USA
PaxVax Inc.
PaxVax Ad4 mgag / Env C150
Completed
EV06
1
Uganda
EuroVacc Foundation
IPPOX DNA-HIV-PT123
Completed
EV07 
1
Uganda
EuroVacc Foundation
IPPOX DNA-HIV-PT123
Completed
PV1 (PrEPVacc)
2b
Uganda, South Africa, Tanzania, Mozambique
Imperial College, London
IPPOX DNA-HIV-PT123
Enrolling

Study Status as of April 2021


PrEPVacc (PV1): A Phase IIb three-arm, two-stage HIV prophylactic vaccine trial with a second randomization to compare TAF/FTC to TDF/FTC as pre-exposure prophylaxis.

Clinical Trial Design Summary

PrEPVacc is an international, multicentre, double-blind vaccine study with a three- arm prospective 1:1:1 randomisation comparing each of two experimental combination vaccine regimens with placebo control:

  • DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48)
  • DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA-CMDR and CN54gp140+MPLA-L (weeks 24,48)
  • Placebo (weeks 0,4,24,48)

In addition, it has a concurrent 1:1 randomisation component comparing two PrEP regimens, open-label:

  • Daily TDF/FTC
  • Daily TAF/FTC

During the progress of the trial, the Independent Data Monitoring Committee will review an interim analysis of vaccine efficacy to determine whether each active vaccine arm has demonstrated sufficient efficacy to warrant further investigation. This analysis will only consider new infections arising after the week 26 visit and only those in individuals who have completed the first three immunisations. The interim analysis will take place after 7 of these infections have occurred in the placebo group.


If both experimental arms continue as planned the study will recruit 556 participants to each arm, a minimum of 1668, each followed for a minimum of 74 weeks from enrolment. The PrEP analysis will consider new infections through to the week 26 visit in individuals who were HIV negative at enrolment.

Primary Outcome Measure(s)

  • Efficacy Outcome for the vaccine analysis: HIV acquisition by a participant who completed the first three immunisations and was HIV negative at week 26.
  • Efficacy Outcome for the PrEP analysis: HIV acquisition at or before week 26 by a participant who was HIV negative at enrolment.
  • Safety Outcome: A clinical decision to discontinue the vaccine or PrEP regimen for an adverse event that is considered related to product.

Results expected by mid-2023


 


Additional Resources

  • AIDSVAX® Program: Overview
  • VaxGen Trials
  • RV144 Trials
  • Clinical Trials
  • AIDSVAX® Collaborators




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Enrollment of volunteers into the PrEPVacc Phase IIb (PV1) clinical trial has started in Uganda. Sites in Tanzania, South Africa and Mozambique to follow soon.
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Global Public Health Consulting