Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00369031
• Date of registration: 24/08/2006
• Prospective Registration: Yes
• Primary sponsor: St George's, University of London
• Public title: Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63
• Scientific title: A Phase I, Open Label, Parallel Group Trial To Evaluate Safety And Immunogenicity Of Three Nasal Immunisations Using A Fixed Dose-Level Of HIV gp140 V2 Loop Deleted Protein Adjuvanted With LTK63 Followed By Intramuscular Boosting With HIV gp140 V2 Loop Deleted Protein Adjuvanted With MF59 When Administered To Healthy Adults
• Date of first enrolment: September 2006
• Target sample size: 31
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00369031
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: David JM Lewis, MD
• Affiliation: St George's, University of London, UK

Key inclusion & exclusion criteria

Inclusion Criteria:

- They are adult volunteers, 18 to 45 years of age, who have signed an informed consent
form following a detailed written explanation of participation in the protocol.

- They are volunteers who are in good health as determined by medical history, physical
examination and clinical judgement.

- They are available for the duration of the study

- They are 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.

Exclusion Criteria:

- They have hypersensitivity to any component of the vaccines used in this study.

- They are found to be HIV antibody positive at the time of initial screening

- They have a known or suspected history of nasal disease, malignancy or abnormality,
or any nasal disease, malignancy or abnormality discovered at time of screening.

- They have a known or suspected history of severe seasonal allergies and allergic
rhinitis (requiring medication), recurrent nose bleeds, asthma, or cardio-pulmonary
disease, or any of these conditions discovered at time of screening.

- They present in the samples obtained at the screening visit:

- a clinically significant amount of protein or haemoglobin in the urine sample,
determined by urine dipstick:

- a clinically significant abnormality in the haematological or biochemical assays

- An abnormal value will be defined by the ranges quoted in the St George's Pathology
Services Handbook.

- They have a known impairment of immune function or are receiving immunosuppressive
therapy (including systemic or inhaled steroids, but excluding topical).

- They are receiving any medications via nasal route.

- They have any acute infections (including fever greater than or equal to 38°C) or any
chronic disease.

- They are women capable of becoming pregnant who do not agree to have pregnancy
testing before application of study products, or who do not agree to take appropriate
contraception measures during the whole study period. Appropriate contraception shall
include physician-prescribed oral, injected or implanted hormonal agents; barrier
contraceptives used in conjunction with spermicidal agents; or intrauterine devices
only.

- 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 which, 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.

- They cannot speak fluent English, or are planning to leave the area of the study site
prior to the end of the study period, or are likely not to complete the study.

- They have a weight (W)/height (H) index (WHI) less than 18.5 or greater than 40



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Biological: Labile Toxin mutant LTK63 adjuvant

Biological: HIV glycoprotein 140 + Labile Toxin mutant LTK63 adjuvant

Biological: Human Immunodeficiency Virus glycoprotein 140 (vaccine)

Primary Outcome(s)

To determine the frequency of vaccine-related local and systemic adverse events after nasal immunisation up to week 32 [Time Frame: 32 weeks]

Secondary Outcome(s)

To determine the frequency of subjects with a serum T-cell response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32 [Time Frame: 32 weeks]

To determine the frequency of vaccine-related local and systemic adverse events after intramuscular immunization up to week 32 [Time Frame: 32 weeks]

To determine frequency of subjects mounting a serum IgG response, nasal IgA response and vaginal IgA response to LTK63 at weeks 0, 4, 8, 10, 12, 16, 28 & 32 [Time Frame: 32 weeks]

To determine the frequency of female subjects mounting a vaginal secretions IgA response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32 [Time Frame: 32 weeks]

To determine the frequency of subjects mounting a serum IgG neutralising antibody response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32 [Time Frame: 32 weeks]

To determine the frequency of subjects mounting a nasal wash gp140-specific IgA response to gp140 at weeks 0, 4, 8, 10, 12, 16, 28 & 32 [Time Frame: 32 weeks]

Secondary ID(s)

FP6-2002-LIFESCIHEA-2.3 503240

2005-005983-10

C86P1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis Vaccines

Richmond Pharmacology Limited

European Union