Abstract
Introduction
Participant's adherence to use of study product is a major concern in microbicide
clinical trials, which can impact on proving product efficacy. In a previously described
assay, single-use microbicide applicators exposed to the vagina were tested by spraying
the applicator with trypan blue dye, resulting in vaginal mucus staining on inserted
applicators. As subjects in our Phase 3 trials return applicators only at quarterly
visits, often mixing inserted and not-inserted applicators together in the same bag,
cross-contamination could confound results. In addition, trypan blue is carcinogenic
and thus potentially hazardous to technicians spraying daily.
Methods
Applicators that were exposed to the vagina were placed in the same bag as unexposed
applicators and shaken daily for up to 4 months. Validation was carried out in three
clinical sites in South Africa.
Results
Trypan blue was replaced with FD&C Blue #1 granular food dye. Cross-contamination
did not occur, nor did the length of time affect reaction to dye. In South Africa,
the assay was validated with an accuracy of over 95%.
Conclusion
Applicator assay modifications render the test safe and suitable for use in clinical
trials.
Keywords
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References
- Assay for establishing whether microbicide applicators have been exposed to the vagina.Sex Transm Dis. 2004; 31: 465-468
Article info
Publication history
Published online: May 11, 2007
Accepted:
October 12,
2006
Received in revised form:
September 13,
2006
Received:
June 29,
2006
Identification
Copyright
© 2007 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
