Safety and Immunogenicity of TBC-M4, a MVA HIV Vaccine Alone or in a Prime-Boost Regimen With ADVAX DNA HIV Vaccine

NCT00902824 | Completed Phase 1 DMC

• 1 other identifier: IAVI P002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will study a prime-boost vaccine approach designed mainly to induce cell-mediated immune (CTL) responses.

Conditions

HIV Infections

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• Safety of TBC-M4 alone or in a prime-boost regimen with ADVAX

  Safety and tolerability of TBC-M4 alone (given im) or in a prime-boost regimen with ADVAX (administered by Biojector)

  12 months

Secondary Outcomes (1)

• Immunogenicity of TBM-M4 alone or in a prime-boost regimen with ADVAX

  12 months

Study Arms (3)

Group A

ACTIVE COMPARATOR

ADVAX at 0,1 and 2 months followed by TBC-M4 at 6 months Number of volunteers: 12

Biological: ADVAX

Group B

ACTIVE COMPARATOR

TBC-M4 at 0,1,6 months Number of volunteers: 12

Biological: TBC-M4

Placebo

PLACEBO COMPARATOR

Both Groups A and B will have 4 volunteers each (8 total) that will receive a placebo.

Other: Placebo

Interventions

ADVAX BIOLOGICAL

Receive 4mg ADVAX at Months 0, 1, and 2 (Biojector), and receive boost of 5x10\^7 pfu TBC-M4 (IM)

Group A

TBC-M4 BIOLOGICAL

Receive 5x10\^7 pfu TBC-M4 (IM) at Months 0, 1, and 6.

Group B

Placebo OTHER

Group A (n=4) will receive the ADVAX placebo (formulation buffer) via Biojector. Group B (n=4) will receive the TBC-M4 placebo (formulation buffer) via IM.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• At least 18 years of age on the day of screening and no greater than 50 years (i.e., had not reached his/her 51st birthday) on the day of 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, has understood the information provided. Written informed consent needs to be given before any study-related procedures are performed;
• Willing to undergo HIV Testing, HIV counselling and receive HIV test results;
• If sexually active female, using an effective method of contraception (hormonal contraceptive; diaphragm; intrauterine device (IUD); condoms; anatomical sterility in self or partner) from screening until at least 4 months after last vaccination. All female volunteers must be willing to undergo urine pregnancy tests at time points as indicated in the Schedule of Procedures (Appendix A);
• If sexually active male, willing to use an effective method of contraception (such as condoms, anatomical sterility) from the day of enrolment until at least 4 months after the last vaccination;
• Willing to forgo donations of blood, sperm, eggs, bone marrow or organs during the study.

You may not qualify if:

• Confirmed HIV-1 or HIV-2 infection;
• High-risk behaviour for HIV infection which is defined as (Within 6 months before vaccination, 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
• Substance abuse/use injection drugs
• Acquired a sexually transmitted disease (STD) (e.g., gonorrhoea, chlamydia, syphilis, Trichomonas vaginalis, and symptomatic herpes genitalis)
• Having a high-risk partner either currently or within the previous 6 months
• Any clinically significant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive, antiviral, anticancer, or other medications considered significant by the investigator within the previous 6 months; (Note: use of inhaled steroids for asthma and 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 investigator would make the volunteer unsuitable for the study;
• Any of the following abnormal laboratory parameters listed below:
• Haemoglobin \<10.0 g/dL
• Absolute Neutrophil Count (ANL): \<1,000/mm3
• Absolute Lymphocyte Count (ALC): \<600/mm3
• Platelets: \<100,000/mm3
• Creatinine: \>1.3 x ULN

Sponsors & Collaborators

• International AIDS Vaccine Initiative: lead

Study Sites (1)

St Stephen's Centre Chelsea and Westminster Hospital

London, London, SW10 9NH, United Kingdom

Location

Related Links

• International AIDS Vaccine Initiative

MeSH Terms

Conditions

HIV Infections

Interventions

delta inulin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Brian Gazzard, MD

  St. Stephen's Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 15, 2009
• Study Start: November 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

GB (1)