Safety & Immunogenicity of HIV Vaccines in Healthy Kenyan Adults
HIV-CORE 004
A Phase I/IIa Clinical Trial of HIV-1 Vaccines pSG2.HIVconsv DNA, MVA.HIVconsv and Ad35-GRIN in Combined Regimens in Healthy HIV-1/2-negative Adults in Nairobi.
1 other identifier
interventional
72
1 country
1
Brief Summary
The study is part of a long-term aim to develop an effective HIV-1 vaccine and will evaluate safety and immunogenicity of vaccines focusing T cell responses on the conserved region of the HIV-1 proteome. The vaccines used are pSG2.HIVconsv DNA (D), MVA.HIVconsv (M) and Ad35-GRIN (A), delivered in regimens AM, DDDAM and DeDeDeAM, where e indicates electroporation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 26, 2014
CompletedFirst Posted
Study publicly available on registry
March 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMay 30, 2016
May 1, 2016
1.4 years
March 26, 2014
May 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vaccine Safety
Proportion of volunteers who develop a grade 3 or 4 local reaction. Proportion of volunteers who develop a grade 3 or 4 systemic reaction
44 weeks
Secondary Outcomes (2)
Vaccine immunogenicity
44 weeks
Vaccine Safety
44 weeks
Study Arms (3)
A - AM
EXPERIMENTALAd35-GRIN 5 x 10\^10 vp IM at week 0, MVA.HIVconsv 2 x 10\^8 pfu IM at week 8.
B - DDDAM
EXPERIMENTALpSG2.HIVconsv DNA 4 mg or saline placebo at weeks 0, 4 and 8. Ad35-GRIN 5 x 10\^10 vp or saline placebo at week 12. MVA.HIVconsv 2 x 10\^8 pfu or saline placebo at week 20.
C - DeDeDeAM
EXPERIMENTALElectroporated pSG2.HIVconsv 4 mg or electroporated saline placebo at weeks 0, 4 and 8. Ad35-GRIN 5 x 10\^10 vp or saline placebo at week 12. MVA.HIVconsv 2 x 10\^8 pfu or saline placebo at week 20.
Interventions
intramuscular administration of Ad35-GRIN 5 x 10\^10 vp or saline placebo
IM administration of MVA.HIVconsv 2 x 10\^8 pfu or saline placebo
IM administration of electroporated pSG2.HIVconsv 4mg or saline placebo
Eligibility Criteria
You may qualify if:
- Healthy adults aged 18-50
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- Written informed consent.
- Willing to undergo HIV-1 testing, counselling and receive test results.
- All female volunteers must be willing to undergo urine pregnancy tests
- If sexually active using an effective method of contraception until at least 4 months after the last vaccination.
- Willing to forgo donating blood during the study.
You may not qualify if:
- Any relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease, or use of systemic corticosteroids, immunosuppressive, antiviral, anticancer or other medication that, in the opinion of the Principal Investigator or designee, is clinically significant, within the previous 6 months. (Note: use of inhaled steroids for asthma or use of topical steroids for localized skin conditions will not exclude a volunteer from participation.)
- Any clinically significant acute or chronic medical condition that is considered progressive or, in the opinion of the Principal Investigator or designee, would make the volunteer unsuitable for the study.
- Any of the following abnormal laboratory parameters (1 abnormal test may be repeated once if thought to be due to a temporary condition):
- Haematology
- Haemoglobin \< 9.0 g/dl for women and \<11.0 g/dl for men
- Absolute Neutrophil Count (ANC) ≤ 1000 /mm3 (≤ 1 x 109 /l)
- Absolute Lymphocyte Count (ALC) ≤ 600 /mm3 (≤0.6 x 109 /l)
- Platelets ≤100,000 /mm3, ≥ 550,000 /mm3 (≤ 100 /l, ≥ 550 /l)
- Biochemistry
- Creatinine \> 1.3 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) \> 2.5 x ULN
- Alanine aminotransferase (ALT) \> 2.5 x ULN
- Urinalysis- Clinically significant abnormal dipstick confirmed by microscopy:
- Protein = 2+ or more
- Blood = 2+ or more (for women: before or after menses)
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- European and Developing Countries Clinical Trials Partnership (EDCTP)collaborator
- International AIDS Vaccine Initiativecollaborator
- Karolinska Institutetcollaborator
- University of Nairobicollaborator
- Ichor Medical Systems Incorporatedcollaborator
Study Sites (1)
KAVI-Kangemi clinic
Nairobi, Kenya
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Jaoko
University of Nairobi
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2014
First Posted
March 31, 2014
Study Start
March 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
May 30, 2016
Record last verified: 2016-05