# Cervicovaginal immune factors throughout the menstrual cycle: analysis of a cohort of Kenyan adolescents, systematic review, and meta-analysis

> **NIH NIH R03** · UNIVERSITY OF WASHINGTON · 2020 · $88,250

## Abstract

PROJECT SUMMARY/ABSTRACT
Quantifying immune mediators within the cervicovaginal tract (CVT) enables researchers to assess
women's susceptibility to HIV and other sexually transmitted infections (STIs). Nearly twenty studies
have been published describing how immune factors in the CVT change during the menstrual cycle.
Despite this abundance of data, we lack a clear picture of the immune changes that occur, and it
remains completely unknown whether a specific phase in the menstrual cycle is associated with
increased disease susceptibility. This knowledge gap has important implications for research on
interventions to reduce STI risk in women. The primary goal of this project is to gain a comprehensive
understanding of how menstrual cycle phase affects immune factor concentrations in the CVT. Our first
aim is to perform a systematic review and meta-analysis of studies that have quantified immune
mediators from CVT specimens during the luteal and follicular phases of the menstrual cycle in women
who are not using hormonal contraception. Our preliminary data indicate that there are at least
seventeen published studies meeting inclusion criteria. In addition to assessing variation during the
menstrual cycle, we will also assess the impact of bacterial vaginosis, STIs (genital herpes, gonorrhea,
and chlamydia), race/ethnicity, and age. We will address technical questions of key importance to the
field, including the effect of CVT sample type, assay type, method of determining menstrual phase, and
data normalization technique. Our second aim is to extend and validate the meta-analysis using
samples from a cohort of 119 Kenyan adolescents ages 16-20 years (with a total of 200 samples). We
will use preliminary results from our first aim to inform which immune factors we select for the Kenyan
cohort, to both increase the number of immune factors that can be included in the meta-analysis and
validate the most important findings. We then plan to add results of this aim to the meta-analysis. As we
show in our preliminary data, by combining data from many studies, we can gain a comprehensive
understanding of mucosal immune changes that impact women's susceptibility to STIs. Understanding
these changes will provide an important foundation for future studies of health interventions (such as
STI prevention strategies, HIV prophylaxis, or hormonal contraception) and drive future research in the
basic immunology of the CVT.

## Key facts

- **NIH application ID:** 10046430
- **Project number:** 1R03AI154366-01
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Florian Hladik
- **Activity code:** R03 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $88,250
- **Award type:** 1
- **Project period:** 2020-07-23 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10046430

## Citation

> US National Institutes of Health, RePORTER application 10046430, Cervicovaginal immune factors throughout the menstrual cycle: analysis of a cohort of Kenyan adolescents, systematic review, and meta-analysis (1R03AI154366-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10046430. Licensed CC0.

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