X001

Status:Completed
Phase:I
Principal Investigator(s):Sarah Fidler, MD
Objective:The purpose is to assess the safety and immunogencicity of a vaccine with two components: a protein immunogen and an adjuvant in different doses.    Last updated March 31, 2021
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Open label, Randomized
Arms and Assigned Interventions
DescriptionVaccination at Months 0, 1, 2 and 6; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionVaccination at Months 0, 1, 2 and 12; each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT01966900
Related Publications:
Molecular Signatures of a TLR4 Agonist-Adjuvanted HIV-1 Vaccine Candidate in Humans
A Phase 1 Human Immunodeficiency Virus Vaccine Trial for Cross-Profiling the Kinetics of Serum and Mucosal Antibody Responses to CN54gp140 Modulated by Two Homologous Prime-Boost Vaccine Regimens
Trial Sponsors: Imperial College London, National Institute for Health Research - United Kingdom, Wellcome Trust
Start Date
End Date
October 31, 2013
November 4, 2015
Enrollment:14
Age range: 18 Years ↔ 45 Years
Population:Cisgender Men, Cisgender Women