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NCT00698490
Study to Compare, in Healthy HSV Seronegative and HSV Seropositive Subjects, the Humoral and Cellular Immune Response of Herpes Simplex Candidate Vaccines Containing gD From Two Different Cell Lines and Using gD-Alum as Control
Phase 1/Phase 2 trial testing Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 in Prophylaxis Herpes Simplex in 130 participants. Completed in 1 January 1997.
1 January 1997
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 130 |
| Start date | 1 August 1995 |
| Primary completion | 1 January 1997 |
| Estimated completion | 1 January 1997 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 — full drug profile →
- Herpes simplex virus containing gD-Alum — 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 45, 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 in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA)
Time frame: After the second and third doses of each vaccine - To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies
-
To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon)
Time frame: After the second and third dose of each vaccine formulation -
To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms
Time frame: During 3 days after each dose of each vaccine -
To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies
Time frame: After 2 and 3 doses of vaccines
Sponsor's own description
The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control.
Publications & conference data
2 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
Verify or expand the search:
- PubMed search for NCT00698490
- 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 NCT00698490 (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: 16 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/NCT00698490.
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