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

HIV-1 Infections Clinical Trial

— HIV-CORE 002  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151319
• Other study ID #: HIV-CORE 002
• Status: Completed
• Phase: Phase 1
• First received: June 24, 2010
• Last updated: April 29, 2014
• Start date: October 2010
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Healthy males or females, as assessed by a medical history, physical examination and laboratory tests.

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:

1. 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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV-1 Infections

Intervention

Biological:
• 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.

Other:
• Placebo
Phosphate buffered saline

Locations

Country	Name	City	State
United Kingdom	Centre for Clinical Vaccinology and Tropical Medicine	Oxford	Oxon

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Proportion of volunteers who develop a grade 3 or 4 local reaction.	Actively collected data throughout the study until 6 months after the last vaccination	Yes
Secondary	Immunogenicity	Proportion of volunteers who develop new CD8+ and CD4+ T cell responses to one or more HIV-1 epitopes, as determined by IFN-? ELISPOT assay.	Samples will be collected at every visit pre- and post vaccination	No
Secondary	Immunogenicity	Exploration of the efficacy of vaccine-induced CD8+ T cells to suppress HIV-1 replication in vitro.	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	No