A randomized, double blind, placebo-controlled, parallel group, pilot study to assess the safety and efficacy of a therapeutic Herpes Simplex Virus-2 (HSV-2) Deoxyribonucleic Acid (DNA) vaccine in HSV-2 positive adults

A Phase l/IIa, randomized, double blind, placebo-controlled, parallel group, pilot study to assess the safety and efficacy of a therapeutic HSV-2 DNA vaccine in HSV-2 positive adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000094572

Enrollment

Registered

2015-02-04

Start date

2015-03-05

Completion date

2016-02-04

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

The aim of this study is to assess the safety and tolerability of the HSV-2 DNA vaccine. We will also investigate whether the vaccine is immunogenic i.e. if it has any effect on the immune system and what type of response is induced. The study will also investigate the vaccine’s effectiveness in combating and/or treating HSV-2 infection

Interventions

HSV-2 DNA Vaccine Two injection regimens of the HSV-2 DNA vaccine will be compared with placebo, administered by intradermal injection as three, 4-weekly doses followed by a 6-month booster. The first injection regime will consist of subjects receiving an injection to each forearm. Once this is fully allocated, the second injection regime will commence recruiting. The second injection regime consists of two injections into the one forearm. Each injection will contain a dose of 500 mcg

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Suffering acute or chronic disease Pregant or nursing females genital HSV-1, Hepatitis B or C, or HIV seropositive Receiving medication known to have anti-HSV-2 activity

Outcome results