At a glance
ClinicalIndex Comparison Record- ✓Aged 18–50 years
- ✓BMI 18–30
- ✓Low risk of HIV (no injecting drug use in past 10 years; no gonorrhoea/syphilis in past 6 months; no high-risk partners; no unprotected anal or vaginal intercourse in past 6 months outside stable HIV-negative relationships)
- ✓Willing to undergo HIV test and genital infection screen
- ✕HIV 1 or 2 positive or indeterminate on screening
- ✕Pregnant or lactating
- ✕History of cardiac arrhythmia, palpitations, syncope, or fainting within 1 year
- ✕History of grand-mal epilepsy, seizure disorder, or any prior seizure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Clinical Trial to Assess the Safety and Immunogenicity of HIV DNA-C CN54ENV Immunisations Administered Via the IM and ID Methods With and Without Electroporation Followed by Boosting With Recombinant HIV CN54gp140 in Healthy Male and Female Volunteers
In Brief
A Phase 1 clinical trial evaluating DNA-C CN54ENV, CN54gp140, and 2 other interventions for HIV. Completed, enrolled 28 participants across 1 site.
Detailed Summary
CUTHIVAC002 is a randomised Phase I study aimed at exploring the safety and immunogenicity of two different modes of delivery of a deoxyribonucleic acid (DNA) vaccine (DNA-C CN54ENV) via combined intramuscular and intradermal methods with and without electroporation, and boosted with recombinant HIV CN54gp140 administered by intradermal injection in healthy volunteers. The aim of this study is to identify optimal DNA delivery conditions for promoting enhanced antibody responses to boosting with recombinant protein by the intradermal method.
Study Details
Timeline
Interventions
DNA plasmid containing the Clade C gp140 envelope gene from HIV-1 isolate CN54
Recombinant protein expressed from the Clade C gp140 envelope gene from HIV-1 isolate CN54
Electroporation
Electroporation