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NCT00697567
Study in Healthy HSV Positive and HSV Negative Adults to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Herpes Simplex (gD) Candidate Vaccine With or Without Adjuvant
Phase 2 trial testing Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant in Prophylaxis Herpes Simplex in 80 participants. Completed in 1 December 1997.
1 December 1997
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 80 |
| Start date | 1 September 1992 |
| Primary completion | 1 December 1997 |
| Estimated completion | 1 December 1997 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant — full drug profile →
- Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant — full drug profile →
Conditions studied
- Prophylaxis Herpes Simplex — all drugs for Prophylaxis Herpes Simplex →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 40, any sex, with Prophylaxis Herpes Simplex. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers
Time frame: Days 0, 30, 60, 180 and 365 after vaccination -
To evaluate the reactogenicity and safety of the MPL-containing and non-MPL-containing vaccine in healthy adult HSV seronegative and seropositive volunteers
Time frame: Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination
Sponsor's own description
The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
A review of HSV pathogenesis, vaccine development, and advanced applications.
Bai L, Xu J, Zeng L, Zhang L, et al · · 2024 · cited 30× · PMID 39207577 · DOI 10.1186/s43556-024-00199-7 -
The Current State of Vaccine Development for Ocular HSV-1 Infection.
Royer DJ, Cohen A, Carr D. · · 2015 · cited 21× · PMID 25983856 · DOI 10.1586/17469899.2015.1004315 -
Tackling cutaneous herpes simplex virus disease with topical immunomodulators-a call to action.
Duarte LF, Carbone-Schellman J, Bueno SM, Kalergis AM, et al · · 2025 · cited 4× · PMID 39982077 · DOI 10.1128/cmr.00147-24
Verify or expand the search:
- PubMed search for NCT00697567
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00697567 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 13 June 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00697567.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing