A Phase I, Proof of Concept, Open Label, Escalating Dose Study to Assess the Safety, Tolerability and Immunogenicity of a Herpes Simplex Virus (HSV) Deoxyribonucleic Acid (DNA) Vaccine

A Phase I, Proof of Concept, Open Label, Escalating Dose Study to Assess the Safety, Tolerability and Immunogenicity of a Herpes Simplex Virus (HSV) Deoxyribonucleic Acid (DNA) Vaccine in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000831785

Enrollment

Registered

2013-07-29

Start date

2013-08-05

Completion date

2013-09-23

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Safety, Tolerability and Immunogenicity of a HSV DNA Vaccine

Interventions

HSV-2 DNA Vaccine There are 5 treatment arms with the first dose being the lowest dose given to Arm 1 and then Arm 2 receives dose 3x greater than Arm 1 and then Arm 3 receives dose 10x greater than Arm 1 and then Arm 4 receives 30x greater than Arm 1 and then Arm 5 receives 100x greater than Arm 1. Each dose is given intradermally 3 times 3 weeks apart. The subject will be monitored 3 weeks post the last vaccination.

Study design

Allocation

Non-randomised trial

Intervention model

Other

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

HSV-1 and 2 seronegative Generally healthy No birthmarks, tattoos, wounds or skin conditions on either forearm

Exclusion criteria

Suffering acute or chronic disease Pregant or nursing females HSV, Hepatitis B or C, or HIV seropositive

Outcome results