Format

Send to

Choose Destination
Clin Infect Dis. 2018 Jun 1;66(12):1928-1936. doi: 10.1093/cid/ciy185.

A Fungal Immunotherapeutic Vaccine (NDV-3A) for Treatment of Recurrent Vulvovaginal Candidiasis-A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial.

Author information

1
Los Angeles Biomedical Research Institute, Torrance.
2
David Geffen School of Medicine at University of California, Los Angeles.
3
NovaDigm Therapeutics, Inc, Boston, Massachusetts.
4
School of Medicine, Wayne State University, Detroit, Michigan.
5
Drexel University College of Medicine, Philadelphia, Pennsylvania.
6
Philimmune LLC, Philadelphia, Pennsylvania.
7
Miami Clinical Research, Corp, Florida.
8
Suffolk Obstetrics & Gynecology, Port Jefferson, New York.
9
TMC Life Research, Inc., Houston, Texas.
10
Lawrence OB-GYN Clinical Research, LLC, Lawrenceville, New Jersey.
11
Research Foundation of SUNY, Albany, New York.
12
Community Medical Research LLC, Miami Beach, Florida.

Abstract

Background:

Recurrent vulvovaginal candidiasis (RVVC) is a problematic form of mucosal Candida infection, characterized by repeated episodes per year. Candida albicans is the most common cause of RVVC. Currently, there are no immunotherapeutic treatments for RVVC.

Methods:

This exploratory randomized, double-blind, placebo-controlled trial evaluated an immunotherapeutic vaccine (NDV-3A) containing a recombinant C. albicans adhesin/invasin protein for prevention of RVVC.

Results:

The study in 188 women with RVVC (n = 178 evaluable) showed that 1 intramuscular dose of NDV-3A was safe and generated rapid and robust B- and T-cell immune responses. Post hoc exploratory analyses revealed a statistically significant increase in the percentage of symptom-free patients at 12 months after vaccination (42% vaccinated vs 22% placebo; P = .03) and a doubling in median time to first symptomatic episode (210 days vaccinated vs 105 days placebo) for the subset of patients aged <40 years (n = 137). The analysis of evaluable patients, which combined patients aged <40 years (77%) and ≥40 years (23%), trended toward a positive impact of NDV-3A versus placebo (P = .099).

Conclusions:

In this unprecedented study of the effectiveness of a fungal vaccine in humans, NDV-3A administered to women with RVVC was safe and highly immunogenic and reduced the frequency of symptomatic episodes of vulvovaginal candidiasis for up to 12 months in women aged <40 years. These results support further development of NDV-3A vaccine and provide guidance for meaningful clinical endpoints for immunotherapeutic management of RVVC.

Clinical Trials Registration:

NCT01926028.

PMID:
29697768
PMCID:
PMC5982716
DOI:
10.1093/cid/ciy185
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Silverchair Information Systems Icon for PubMed Central
Loading ...
Support Center