HIV Vaccine Study in HIV Positive Patients

NCT01071031 | Completed Phase 1

• 1 other identifier: HIV-v-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of the study is to see whether a single vaccination (injection) with the investigational HIV vaccine is safe and effective in patients who are HIV positive but have not yet begun anti-retroviral therapy. As this is an exploratory study, four different dose formulations of HIV vaccine will be investigated. This study will evaluate whether or not the HIV vaccine is able to reduce the HIV viral load (number of HIV virus particles in the blood) and increase or slow the decline in CD4 T cell count.

Conditions

HIV Infections

Keywords

Safety; Tolerability; Immunogenicity; Human Immunodeficiency Virus; HIV-1; Vaccine; CD4; Viral Load; HIV

Outcome Measures

Primary Outcomes (1)

• To demonstrate the safety and tolerability of the PepTcell HIV vaccine by analysis of safety data including changes in HIV load and CD4 T cell count.

  Pre-vaccination, days 1, 2, 7, 14, 21 and 28 after vaccination and weeks 8, 12, 16, 20 and 24 after vaccination

Study Arms (5)

Group 1

EXPERIMENTAL

Low Dose HIV-v with water for injection

Biological: HIV-v (Low Dose)

Group 2

EXPERIMENTAL

Low Dose HIV-v with adjuvant

Biological: HIV-v (Low Dose)

Group 3

EXPERIMENTAL

High Dose HIV-v with water for injection

Biological: HIV-v (High Dose)

Group 4

EXPERIMENTAL

High Dose HIV-v with adjuvant

Biological: HIV-v (High Dose)

Group 5

PLACEBO COMPARATOR

Control group: adjuvant only or water for injection only

Biological: HIV-v (Control)

Interventions

HIV-v (Low Dose) BIOLOGICAL

Low Dose HIV-v (a sterile lyophilised mixture of polypeptide T-cell epitope sequences) with water for injection or adjuvant Administration: A single subcutaneous injection

Group 1; Group 2

HIV-v (High Dose) BIOLOGICAL

High Dose HIV-v (a sterile lyophilised mixture of polypeptide T-cell epitope sequences with water for injection or adjuvant Administration: A single subcutaneous injection

Group 3; Group 4

HIV-v (Control) BIOLOGICAL

Adjuvant only or Water for injection only Administration: A single subcutaneous injection

Group 5

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects age 18 - 50 years inclusive with HIV-1 infection
• Documented as HIV positive, with viral loads higher than 5,000 copies per millilitre of blood, but less than 500,000 using either a branched DNA test, or an RT-PCR test
• CD4 T cell count \>350/mm3
• Clinically stable in the opinion of the investigator and not expected to require anti-retroviral therapy during the course of the study
• No evidence of any AIDS defining illness
• Subjects with male or female partners must agree to use a barrier method of protection against disease transmission during intercourse (e.g. condom).
• Subjects whose female partners are of child-bearing potential must also agree to use a second contraceptive method (e.g. spermicidal agent, IUD, hormonal contraceptive) in addition to a condom for the duration of the study.
• Provide written informed consent to participate in the study and be willing to comply with all study procedures.

You may not qualify if:

• Participation in a clinical trial or receipt of an experimental therapy within 30 days prior to study dosing
• Receipt of another vaccine 30 days before or 30 days after HIV-v
• Currently receiving anti-viral, anti-retroviral therapy or any chronic anti-infective therapy
• Receiving, or have received over the previous two weeks, any treatment that might modulate the immune response after vaccination, including, but not limited to, immunosuppressive therapy and systemic corticosteroids
• Suffers from a disease or is undergoing treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (\>800µg/day beclometasone or equivalent), radiation treatment or cytotoxic drugs
• Received a blood transfusion or immunoglobulins within 90 days prior to study entry
• Patients on inhaled corticosteroids for asthma or other respiratory conditions
• Subjects having an infective exacerbation during the screening process as defined as a requirement of inhaled, oral, or intravenous antibiotics prior to the first study dose will be excluded
• Use of non-steroidal anti-inflammatory drugs (NSAIDs) or any over-the-counter product, herbal product, diet aid, hormone supplement, etc., within 14 days prior to vaccination or any planned administration of these products over the course of the first 28 days after vaccination (unless approved by both the Principal Investigator and the Sponsor)
• Patients with Hepatitis B or C co-infection (though serological evidence of previous hepatitis C infection with no evidence of carrier status is acceptable)
• Suffers from or has a history of significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, haematological or renal disorder
• Subjects with clinically significant out of range laboratory values as stated in Section 8.6 of the protocol
• Patients with a history of significant or allergic reaction to vaccines
• Patients with a known or suspected dependence on illicit drugs or alcohol and those undergoing illicit drug replacement programmes
• Is direct employee of the study site or monitoring CRO

Sponsors & Collaborators

• PepTcell Limited: lead

Study Sites (5)

Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital

London, London, E1 1BB, United Kingdom

Location

St. Stephen's Centre, Chelsea and Westminster Foundation Trust

London, London, SW10 9NH, United Kingdom

Location

Elton John Centre, Sussex House,

Brighton, BN2 1ES, United Kingdom

Location

North Manchester General Hospital, Department for Infectious Diseases

Manchester, M8 5RB, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

Related Publications (1)

• Boffito M, Fox J, Bowman C, Fisher M, Orkin C, Wilkins E, Jackson A, Pleguezuelos O, Robinson S, Stoloff GA, Caparros-Wanderley W. Safety, immunogenicity and efficacy assessment of HIV immunotherapy in a multi-centre, double-blind, randomised, Placebo-controlled Phase Ib human trial. Vaccine. 2013 Nov 19;31(48):5680-6. doi: 10.1016/j.vaccine.2013.09.057. Epub 2013 Oct 8.

  PMID: 24120550 DERIVED

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

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; Slow Virus Diseases

Study Officials

• Marta Boffito, MD PhD

  St Stephen's Aids Trust

  PRINCIPAL INVESTIGATOR

• Stuart Robinson

  PepTcell Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: November 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 26, 2012

Record last verified: 2012-09

Locations

GB (5)