Safety and Immunogenicity Study of Three Candidate HIV-1 Vaccines, Administered in Combination to Healthy HIV-1 Uninfected Adults
NCT ID: NCT01151319
Last Updated: 2014-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2010-10-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Stage 1.
The first stage will start from a low and well tolerated, but likely less immunogenic dose of ChAdV63.HIVconsv (n=2).
ChAdV63.HIVconsv low dose.
Attenuated chimp adenovirus. 5x10\^9 virus particles.
Stage 2
The highest dose of ChAdV63.HIVconsv followed by boost with MVA.HIVconsv at week 0 and 8, respectively (n=8). Followed up at 6,12 and 24 months after last vaccination.
ChAdV63.HIVconsv high dose.
Attenuated chimp adenovirus at 5x10\^10 virus particles.
MVA.HIVconsv
Attenuated poxvirus at 4x10\^8 plaque forming units per dose.
Stage 3
Three doses of pSG2.HIVconsv DNA followed by boost with high dose ChAdV63.HIVconsv followed by boost with MVA.HIVconsv at week 0,4,8,12 and 20, respectively (n=8). Followed up at 6, 12 and 24 months after last vaccination.
ChAdV63.HIVconsv high dose.
Attenuated chimp adenovirus at 5x10\^10 virus particles.
pSG2.HIVconsv
DNA at 4mg per dose.
MVA.HIVconsv
Attenuated poxvirus at 4x10\^8 plaque forming units per dose.
Stage 4
Three doses of pSG2.HIVconsv DNA followed by boost with MVA.HIVconsv followed by boost with high dose ChAdV63.HIVconsv at weeks at week 0,4,8,12 and 16, respectively (n=8).
ChAdV63.HIVconsv high dose.
Attenuated chimp adenovirus at 5x10\^10 virus particles.
pSG2.HIVconsv
DNA at 4mg per dose.
MVA.HIVconsv
Attenuated poxvirus at 4x10\^8 plaque forming units per dose.
Stage 2 Placebo
Time-course matched to vaccinations (n=2)
Placebo
Phosphate buffered saline
Stage 3 placebo
Time-course matched to vaccinations (n=2)
Placebo
Phosphate buffered saline
Stage 4 placebo
Time-course matched to vaccinations (n=2)
Placebo
Phosphate buffered saline
Interventions
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ChAdV63.HIVconsv low dose.
Attenuated chimp adenovirus. 5x10\^9 virus particles.
ChAdV63.HIVconsv high dose.
Attenuated chimp adenovirus at 5x10\^10 virus particles.
pSG2.HIVconsv
DNA at 4mg per dose.
MVA.HIVconsv
Attenuated poxvirus at 4x10\^8 plaque forming units per dose.
Placebo
Phosphate buffered saline
Eligibility Criteria
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Inclusion Criteria
2. Aged at least 18 years on the day of screening and no greater than 50 years on the day of the first vaccination.
3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
4. In the opinion of the principal investigator or designee, the volunteer has understood the information provided. Written informed consent must be given before any study-related procedures are performed.
5. Willing to undergo HIV-1 testing, HIV-1 counselling and receive HIV-1 test results.
6. If heterosexually active female; using an effective method of contraception (e.g. hormonal contraception, diaphragm, intra-uterine device (IUD), condoms, anatomical sterility in self or partner) from 14 days prior to the first vaccination until at least 6 weeks after the last vaccination; all female volunteers must be willing to undergo urine pregnancy tests at time points specified in the protocol.
7. If heterosexually active male; willing to use an effective method of contraception (condoms; anatomical sterility in self or partner) from the day of the first vaccination until 6 weeks after the last vaccination.
8. Willing to forgo donations of blood during the study.
Exclusion Criteria
2. Any of the following abnormal laboratory parameters listed below:
Haematology
* Haemoglobin \< 10.0 g/dl
* Absolute Neutrophil Count (ANC) ≤ 1000 /mm3 (≤ 1 x 109 /l)
* Absolute Lymphocyte Count (ALC) ≤ 600 /mm3 (≤ 1 x 109 /l)
* Platelets ≤100,000 /mm3, ≥ 550,000 /mm3 (≤ 90 /l, ≥ 550 /l) Biochemistry
* Creatinine \> 1.3 x ULN
* Aspartate aminotransferase (AST) \> 2.5 x ULN
* Alanine aminotransferase (ALT) \> 2.5 x ULN Urinalysis
* Abnormal dipstick confirmed by microscopy
3. Reported high-risk behaviour for HIV infection. High-risk behaviour for HIV-1 infection is defined as follows. Within the previous 6 months the volunteer has:
* Had unprotected vaginal or anal sex with a known HIV-infected person or a casual partner (i.e., no continuing, established relationship)
* Engaged in sex work for money or drugs
* Used injection drugs
* Acquired one of the following sexually transmitted disease (STD); Chlamydia, gonorrhoea and syphilis.
4. Confirmed HIV-1 or HIV-2 infection.
5. If female, pregnant or planning a pregnancy within 6 weeks after last vaccination; or lactating.
6. Receipt of live attenuated vaccine within the previous 60 days (live attenuated flu vaccine within 14 days) or planned receipt within 60 days after vaccination with Investigational Product or receipt of other vaccine within the previous 14 days or planned receipt within14 days after vaccination with Investigational Product.
7. Receipt of blood transfusion or blood products within the previous 6 months.
8. Participation in another clinical trial of an Investigational Product currently, within the previous 3 months or expected participation during this study.
9. Receipt of any investigational HIV vaccine within the last 6 years.
10. History of severe or very severe local or systemic reactogenicity events, or history of severe or very severe allergic reactions.
11. Confirmed diagnosis of hepatitis B virus (surface antigen, HBsAg), hepatitis C virus (HCV antibodies) or active syphilis.
12. Smallpox vaccination within the previous 3 years (smallpox vaccination prior to 3 years should be documented but is not an exclusion criterion).
13. Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicidal attempt or ideation in the previous 3 years.
18 Years
50 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Tomas Hanke
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Lucy Dorrell
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxon, United Kingdom
Countries
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References
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Moyo N, Borthwick NJ, Wee EG, Capucci S, Crook A, Dorrell L, Hanke T. Long-term follow up of human T-cell responses to conserved HIV-1 regions elicited by DNA/simian adenovirus/MVA vaccine regimens. PLoS One. 2017 Jul 18;12(7):e0181382. doi: 10.1371/journal.pone.0181382. eCollection 2017.
Borthwick N, Lin Z, Akahoshi T, Llano A, Silva-Arrieta S, Ahmed T, Dorrell L, Brander C, Murakoshi H, Takiguchi M, Hanke T. Novel, in-natural-infection subdominant HIV-1 CD8+ T-cell epitopes revealed in human recipients of conserved-region T-cell vaccines. PLoS One. 2017 Apr 27;12(4):e0176418. doi: 10.1371/journal.pone.0176418. eCollection 2017.
Hayton EJ, Rose A, Ibrahimsa U, Del Sorbo M, Capone S, Crook A, Black AP, Dorrell L, Hanke T. Safety and tolerability of conserved region vaccines vectored by plasmid DNA, simian adenovirus and modified vaccinia virus ankara administered to human immunodeficiency virus type 1-uninfected adults in a randomized, single-blind phase I trial. PLoS One. 2014 Jul 9;9(7):e101591. doi: 10.1371/journal.pone.0101591. eCollection 2014.
Other Identifiers
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HIV-CORE 002
Identifier Type: -
Identifier Source: org_study_id