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HIV-1 InfectionsPhase 1HIV-CORE 002NCT01151319

Safety and Immunogenicity Study of Three Candidate HIV-1 Vaccines, Administered in Combination to Healthy HIV-1 Uninfected Adults

A Phase 1 study testing ChAdV63.HIVconsv low dose., ChAdV63.HIVconsv high dose. and pSG2.HIVconsv in people with HIV-1 Infections, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomised, placebo-controlled, single-blind study designed to evaluate the safety and immunogenicity of three novel HIV vaccines. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
HIV-1 Infections
What is being tested?
ChAdV63.HIVconsv low dose., ChAdV63.HIVconsv high dose. and pSG2.HIVconsv
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2010to Apr 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males or females, as assessed by a medical history, physical examination and laboratory tests.
  • Aged at least 18 years on the day of screening and no greater than 50 years on the day of the first vaccination.
  • Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
  • 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.
  • Willing to undergo HIV-1 testing, HIV-1 counselling and receive HIV-1 test results.
  • 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.
  • 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.
  • Willing to forgo donations of blood during the study.

Who cannot join

  • 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 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)
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  • 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
  • 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.
  • Confirmed HIV-1 or HIV-2 infection.
  • If female, pregnant or planning a pregnancy within 6 weeks after last vaccination; or lactating.
  • 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.
  • Receipt of blood transfusion or blood products within the previous 6 months.
  • Participation in another clinical trial of an Investigational Product currently, within the previous 3 months or expected participation during this study.
  • Receipt of any investigational HIV vaccine within the last 6 years.
  • History of severe or very severe local or systemic reactogenicity events, or history of severe or very severe allergic reactions.
  • Confirmed diagnosis of hepatitis B virus (surface antigen, HBsAg), hepatitis C virus (HCV antibodies) or active syphilis.
  • Smallpox vaccination within the previous 3 years (smallpox vaccination prior to 3 years should be documented but is not an exclusion criterion).
  • Major psychiatric illness including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, suicidal attempt or ideation in the previous 3 years.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Centre for Clinical Vaccinology and Tropical Medicine

    Oxford, Oxon, OX3 9DZ

Other trials in United Kingdom

About this study

Official title: A Randomized Single-blind Placebo-controlled Study to Evaluate the Safety and Immunogenicity of Three Candidate HIV-1 Vaccines, pSG2.HIVconsv DNA, ChAdV63.HIVconsv and MVA.HIVconsv, Administered in Combination to Healthy HIV 1 Uninfected Adults

This is a randomised, placebo-controlled, single-blind study designed to evaluate the safety and immunogenicity of three novel HIV vaccines.

Being tested
ChAdV63.HIVconsv low dose., ChAdV63.HIVconsv high dose., pSG2.HIVconsv, MVA.HIVconsv, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChAdV63.HIVconsv low dose.Biological

    Attenuated chimp adenovirus. 5x10^9 virus particles.

  • ChAdV63.HIVconsv high dose.Biological

    Attenuated chimp adenovirus at 5x10^10 virus particles.

  • pSG2.HIVconsvBiological

    DNA at 4mg per dose.

  • MVA.HIVconsvBiological

    Attenuated poxvirus at 4x10^8 plaque forming units per dose.

  • PlaceboOther

    Phosphate buffered saline

Study groups in NCT01151319
Study groupRoleWhat they receive
Stage 1.ExperimentalThe first stage will start from a low and well tolerated, but likely less immunogenic dose of ChAdV63.HIVconsv (n=2).
Receives: Biological: ChAdV63.HIVconsv low dose.
Stage 2ExperimentalThe 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.
Receives: Biological: ChAdV63.HIVconsv high dose.; Biological: MVA.HIVconsv
Stage 3ExperimentalThree 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.
Receives: Biological: ChAdV63.HIVconsv high dose.; Biological: pSG2.HIVconsv; Biological: MVA.HIVconsv
Stage 4ExperimentalThree 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).
Receives: Biological: ChAdV63.HIVconsv high dose.; Biological: pSG2.HIVconsv; Biological: MVA.HIVconsv
Stage 2 PlaceboPlacebo comparatorTime-course matched to vaccinations (n=2)
Receives: Other: Placebo
Stage 3 placeboPlacebo comparatorTime-course matched to vaccinations (n=2)
Receives: Other: Placebo
Stage 4 placeboPlacebo comparatorTime-course matched to vaccinations (n=2)
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    Proportion of volunteers who develop a grade 3 or 4 local reaction.

    Measured: Actively collected data throughout the study until 6 months after the last vaccination

Secondary outcomes (2)

  1. Immunogenicity

    Proportion of volunteers who develop new CD8+ and CD4+ T cell responses to one or more HIV-1 epitopes, as determined by IFN-γ ELISPOT assay.

    Measured: Samples will be collected at every visit pre- and post vaccination

  2. Immunogenicity

    Exploration of the efficacy of vaccine-induced CD8+ T cells to suppress HIV-1 replication in vitro.

    Measured: Stage 1; screen, 0, 1, 2, 4, 8, 16, 28 wk. Stage 2; screen, 0, 1, 2, 4, 8, 9, 12, 20, 28 wk. Stage 3; screen, 1, 8, 12, 13, 14, 20, 21, 22, 28 wk. Stage 4; screen, 0, 8, 12, 13, 16, 17, 18, 24, 28 wk post vac. Stage 2 & 3: 6,12,24 mth after last vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01151319
Sponsor's protocol ID
HIV-CORE 002
Acronym
HIV-CORE 002
Status last verified
Apr 2014
First submitted
24 Jun 2010
Last updated
30 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28719652

  • 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.

    PubMed 28448594

  • 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.

    PubMed 25007091

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ChAdV63.HIVconsv low dose., ChAdV63.HIVconsv high dose. and pSG2.HIVconsv in people with HIV-1 Infections, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: Actively collected data throughout the study until 6 months after the last vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01151319, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2014.

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