Reactogenicity and Immunogenicity of Cervico-vaginal CN54gp140-hsp70 Conjugate Vaccine

NCT01285141 | Completed Phase 1

• 1 other identifier: 2010-022740-20
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

A vaccine to prevent infection with the Human Immunodeficiency Virus (HIV) is urgently needed. Worldwide, most HIV infections occur through sex between a man and woman. The vaccine in this study consists of a protein from HIV that has been synthetically produced and linked to a protein that boosts immune responses. It has not been tested in humans before, but it is expected (from animal studies) that direct application into the female genital tract (via the vagina) as liquid drops, will provoke immune protection at the site of HIV infection. This is less applicable to men, therefore only healthy, HIV negative women will be recruited. The investigators will recruit at one site, which is a university vaccine research centre with experience of running similar trials. The study will last 24 weeks during which subjects will have blood samples taken on six visits, and three immunisations over 12 weeks in which 1 millilitres of vaccine is placed into the vaginal by inserting a small plastic syringe. The purpose of this initial small study is to monitor safety of the vaccine and to determine whether it is appropriate to continue into future, larger studies in which the immune response to the vaccine is measured.

Conditions

HIV Infections

Keywords

HIV Infections; Acquired Immune Deficiency Syndrome

Outcome Measures

Primary Outcomes (1)

• Frequency of local immunisation site vaccine-related Adverse Events

  Semi-structured diary card of solicited local symptoms (vaginal irritation, discharge, bleeding), investigator-prompted recall of unsolicited symptoms, recorded for 20 weeks from day of first immunisation. Visual inspection of cervix-vagina by trained operator prior to immunisation and on final visit.

  20 weeks

Secondary Outcomes (7)

• Frequency of generalised vaccine-related Adverse Events

  20

• Frequency of vaccine-related Adverse Events in hematology and serum biochemistry parameters

  20

• Frequency of subjects mounting a cervico-vaginal antibody response to CN54gp140

  20 weeks

• Frequency of subjects mounting a cervico-vaginal antibody response to hsp70

  20 weeks

• Frequency of subjects mounting a T cellular proliferative response to CN54gp140

  20 weeks

Study Arms (1)

Vaginal immunisation

EXPERIMENTAL

CN54gp140 glycoprotein-hsp70 conjugate vaccine

Biological: CN54gp140 glycoprotein-hsp70 conjugate vaccine

Interventions

CN54gp140 glycoprotein-hsp70 conjugate vaccine BIOLOGICAL

CN54gp140-hsp70 conjugate vaccine administered intravaginally 3 times over a 12-week period

Also known as: ZM96gp140 glycoprotein

Vaginal immunisation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult female volunteers, 18 to 45 years of age, who have signed an informed consent form following a detailed written explanation of participation in the protocol.
• Volunteers who are in good health as determined by medical history, physical examination and clinical judgement.
• Available for the duration of the study.
• Women who, if capable of becoming pregnant during the study, have agreed to have a pregnancy test immediately before immunisation, and to use appropriate contraception methods during the whole study period. Appropriate contraception shall include physician-prescribed oral hormonal agents, barrier contraceptives, regular and consistent use of condoms without spermicidal agents, or intrauterine devices only.
• Agree not to undertake any vaginal practices other than receptive intercourse with a male or use of sanitary tampons during menses. Use of condoms without spermicidal agents is encouraged.
• Have not donated blood during 3 months prior to study entry and agree to not donate for 3 months after the end of their participation in the study

You may not qualify if:

• They have hypersensitivity to any component of the vaccine used in this study.
• They are found to be HIV antibody or HIV proviral DNA positive at the time of initial screening.
• They have a known or suspected history of cervico-vaginal disease, malignancy or abnormality discovered at time of screening, or who have undergone a Letts procedure.
• They present in the samples obtained at the screening visit:
• a clinically significant abnormality in the haematological or biochemical assays.
• Positive tests for Hepatitis B and/or C infection
• Positive tests for genital infections: Chlamydia trachomatis, Neisseria gonorrhoea, Treponema pallidum (syphilis).
• An abnormal value will be defined by the ranges quoted by pathology laboratory.
• They have a known or suspected impairment of lung, heart, liver, kidney, blood disorders or immune dysfunction.
• They are receiving immunosuppressive therapy (including systemic steroids).
• They are receiving any regular medications via vaginal route.
• They have any acute infections (including fever greater than or equal to 38°C) or any chronic disease.
• They present a current problem with substance abuse or with a history of substance abuse, which, in the opinion of the investigator, might interfere with participation in the study.
• They have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
• They have received an investigational agent within 3 months prior to study entry.

Sponsors & Collaborators

• St George's, University of London: lead
• European Union: collaborator

Study Sites (1)

St George's - University of London

London, England, SW17 0RE, United Kingdom

Location

Related Publications (1)

• Lewis DJ, Wang Y, Huo Z, Giemza R, Babaahmady K, Rahman D, Shattock RJ, Singh M, Lehner T. Effect of vaginal immunization with HIVgp140 and HSP70 on HIV-1 replication and innate and T cell adaptive immunity in women. J Virol. 2014 Oct;88(20):11648-57. doi: 10.1128/JVI.01621-14. Epub 2014 Jul 9.

  PMID: 25008917 DERIVED

Related Links

• St George's, University of London

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

• David JM Lewis, MD

  St George's, University of London, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Vaccinology

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 27, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 5, 2012

Record last verified: 2012-12

Locations

GB (1)