Safety and Immunogenicity of MVA.HIVconsv in HIV-1 Seropositive Adults on HAART

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-11-30

Brief Summary

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In this study, the novel vaccine candidate, MVA.HIVconsv, will be tested for safety, tolerability and immunogenicity in HIV-1-seropositive subjects receiving effective antiretroviral therapy.

MVA.HIVconsv will be tested as a single vaccine modality, as a prelude to testing in a heterologous viral vector boost regimen which will include a replication-defective simian adenovirus expressing the same immunogen.

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Detailed Description

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Conditions

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HIV-1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low dose vaccinees

Individuals will receive three intramuscular injections of MVA.HIVconsv alone at a dose of 1x10\^8 pfu.

Group Type EXPERIMENTAL

MVA.HIVconsv low dose

Intervention Type BIOLOGICAL

Three intramuscular injections of MVA.HIVconsv alone at a dose of 1x10\^8 pfu at week 0, 4 and 12.

High dose vaccinees

Individuals will receive three intramuscular injections of MVA.HIVconsv alone at a dose of 4x10\^8 pfu.

Group Type EXPERIMENTAL

MVA.HIVconsv high dose

Intervention Type BIOLOGICAL

Three intramuscular injections of MVA.HIVconsv alone at a dose of 4x10\^8 pfu at week 0, 4 and 12.

Low dose placebo

Individuals will receive three intramuscular injections of low dose placebo

Group Type PLACEBO_COMPARATOR

Placebo low dose

Intervention Type OTHER

Three intramuscular injections of placebo alone (200ul) at week 0, 4 and 12.

High dose placebo

Individuals will receive three intramuscular injections of high dose placebo

Group Type PLACEBO_COMPARATOR

Placebo high dose

Intervention Type OTHER

Three intramuscular injections of placebo alone (800ul) at week 0, 4 and 12.

Interventions

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MVA.HIVconsv low dose

Three intramuscular injections of MVA.HIVconsv alone at a dose of 1x10\^8 pfu at week 0, 4 and 12.

Intervention Type BIOLOGICAL

Placebo low dose

Three intramuscular injections of placebo alone (200ul) at week 0, 4 and 12.

Intervention Type OTHER

MVA.HIVconsv high dose

Three intramuscular injections of MVA.HIVconsv alone at a dose of 4x10\^8 pfu at week 0, 4 and 12.

Intervention Type BIOLOGICAL

Placebo high dose

Three intramuscular injections of placebo alone (800ul) at week 0, 4 and 12.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 18-60 years
* Confirmed HIV-1 seropositive
* Willing and able to give written informed consent for participation in the study
* Treated continuously with a combination of 3 or more antiretroviral agents for the preceding 12 months
* Willing and able to adhere to an effective ART regimen for the duration of the study (switching from current regimen is allowed if for reasons of tolerability or toxicity)
* CD4 cell count \> 350 cells/μl at screening and at the preceding clinic visit
* Plasma viral load \< 50 copies / ml at screening and at the preceding clinic visit
* No new AIDS-defining diagnosis or progression of HIV-related disease in the preceding 6/12 months
* Haematological and biochemical laboratory parameters as follows:

* Haemoglobin \> 10g/dl
* Platelets \> 100,000/μl
* ALT ≤ 2.5 x ULN
* Creatinine ≤ 1.3 x ULN
* Serology: negative for hepatitis B surface antigen OR HbsAg positive with HBV DNA \< 1000 copies/ml; negative for hepatitis C antibodies OR confirmed clearance of HCV infection (spontaneous or following treatment); negative syphilis serology or documented adequate treatment of syphilis if positive EIA IgG or TPHA
* Available for follow up for duration of study (screening + 38 weeks) and willing to comply with the protocol requirements
* Women of child-bearing age must not be pregnant, planning a pregnancy or breast-feeding. Sexually active women must be willing to use an approved method of contraception from screening until 4 months after the third immunisation. Sexually active men in heterosexual relationships must be willing to use an approved method of contraception with their partners from screening until 4 months after the third immunisation.

Exclusion Criteria

* Confirmed HIV-2 seropositive
* Positive pregnancy test
* Participation in another clinical trial within 12 weeks of study entry
* History of autoimmune disease other than HIV-related auto-immune disease which has resolved with ART
* History or clinical manifestations of any physical or psychiatric disorder which could impair the subject's ability to complete the study
* History of anaphylaxis or severe adverse reaction to vaccines
* History of alcohol or drug dependency which could, in the opinion of the investigators, impair the subject's ability to complete the study
* Previous immunisation with a recombinant MVA vaccine
* Immunisation with any experimental immunogens within 6 months of study entry
* Receipt of blood products or immunoglobulins within 6 months of study entry
* Treatment for cancer or lymphoproliferative disease within 1 year of study entry
* Receipt of vaccines other than Hepatitis B vaccine within 2 weeks of study entry or planned receipt within 2 weeks of vaccination
* Any other prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study
* Current or recent use (within last 3 months) of interferon or systemic corticosteroids or other immunosuppressive agents

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No