About

Michele P Andrasik is an Affiliate Associate Professor in the Department of Global Health at the University of Washington and an Affiliate Associate Professor in Environmental and Occupational Health Sciences at the Fred Hutch Cancer Center. Her work focuses on addressing psychosocial and structural factors associated with HIV risk and STI disparities among marginalized communities in the United States. She has developed collaborative and reciprocal relationships between researchers, community members, and organizations to tackle existing health disparities. Dr. Andrasik's efforts include improving behavioral risk assessment, enrollment, recruitment, and retention in preventive HIV vaccine trials through her work with the HIV Vaccine Trials Network (HVTN). She also works to address the impact of stigma on disparities across the HIV care continuum. She holds a doctoral degree in Clinical Health Psychology from the University of Miami and has expertise in Community-Based Participatory Research approaches and Qualitative methods. Her background includes working as Director of AIDS services for a community-based organization in Brooklyn and Manhattan. Currently, she is the lead Behavioral Scientist at FHCRC’s HVTN, a Clinical Assistant Professor at UW, and a Core Faculty member in the FHCRC/UW Center for AIDS Research Sociobehavioral Prevention Research Core.

Research topics

• Medicine
• Internal medicine
• Gerontology
• Sociology
• Social psychology
• Psychology
• Demography
• Immunology
• Virology
• Psychiatry
• Chemistry
• Biology
• Family medicine
• Environmental health
• Clinical psychology
• Anthropology
• Nursing

Selected publications

• Correlates of severe and delta COVID-19 in a phase 3 trial of the AZD1222 vaccine

  npj Vaccines · 2026-04-18

  articleOpen access

  In the phase 3 AZD1222 COVID-19 vaccine trial, anti-Spike (vaccine-matched and Delta) binding IgG antibody concentration and neutralizing antibody (nAb) titer (vaccine-matched+D614G and Delta), measured four weeks post-dose two (D57), were assessed as correlates of risk of severe COVID-19 and Delta COVID-19 over ~4 to ~13 months (severe) or ~11 months (Delta) post-D57. Using a case-control design, antibodies were measured in baseline SARS-CoV-2-negative per-protocol ChAdOx1 nCoV-19 recipients (19 severe COVID-19 cases, 57 Delta COVID-19 cases, 111 controls). The hazard ratio (HR) of severe COVID-19 per 10-fold vaccine-matched D57 marker increase was 0.16 (95% CI: 0.05, 0.54; p = 0.004) for Spike IgG and 0.13 (0.03, 0.59; p = 0.009) for nAb titer. D57 Delta antibodies were weak correlates of Delta COVID-19: HR per 10-fold increase 0.70 (0.14, 3.47; p = 0.66) for Delta Spike IgG; 0.46 (0.14, 1.47; p = 0.19) for Delta nAb titer. Binding and nAb levels strongly predicted severe COVID-19, even with antibody waning.

  PublisherOA PDFDOI

• Analytical treatment interruption among women with HIV in southern Africa who received VRC01 or placebo in the Antibody Mediated Prevention Study: ATI stakeholder engagement, implementation and early clinical data

  Journal of the International AIDS Society · 2025-06-01 · 3 citations

  articleOpen access

  INTRODUCTION: Antiretroviral therapy (ART) prevents and treats, but does not eradicate, HIV. Early ART initiation is associated with post-ART virologic control, particularly among African women, and anti-HIV-1 broadly neutralizing antibodies (bnAbs) may modulate immune responses to HIV. We evaluate whether early ART with or without anti-HIV-1 bnAb VRC01, present at HIV acquisition, is associated with later ART-free control in African women and we assess potential associations with observed control. METHODS: Stakeholder engagement informed analytical treatment interruption (ATI) study design and implementation. Participants who received placebo or VRC01 and acquired HIV in the Antibody Mediated Prevention efficacy trial were assessed for ATI eligibility, including HIV acquisition within 8 weeks of receiving VRC01 or placebo, followed by early ART initiation and ≥1 year of viral suppression. Participation facilitators and barriers were assessed. From May 2021 to February 2024, participants enrolled, stopped ART and received frequent viral load and CD4+ T-cell count monitoring for safety and assessment of meeting ART reinitiation criteria. RESULTS: Thirteen women enrolled from southern Africa. No ATI-related serious adverse events (AEs), HIV transmissions, pregnancies or ≥Grade 2 AEs were observed. Eight sexually transmitted infections were diagnosed in seven women during ATI. Two participants had tenofovir levels consistent with use during ATI; 2/11 (18%) who completed ATI without antiretroviral use exhibited ART-free control for ≥32 weeks. The median time to confirmed VL≥200 was 5.4 weeks (range 2.7-112). The most common ART reinitiation criterion met was virologic (n = 7). VRC01 receipt proximate to HIV acquisition was not associated with control. Controllers versus non-controllers did not differ by early post-acquisition viral load kinetics, acquired virus characteristics, or time from estimated acquisition to closest infusion or to ART initiation. CONCLUSIONS: In a safe, well-tolerated ATI, 18% of 11 African women exhibited post-intervention control. Design and implementation lessons inform future ATIs in Africa. Analyses of peri-acquisition and post-ATI host and viral characteristics can inform the development of interventions for HIV cure, prevention and treatment. CLINICAL TRIAL REGISTRATION: NCT04860323.

  PublisherOA PDFDOI

• Evaluating the Test-Negative Design for COVID-19 Vaccine Effectiveness Using Randomized Trial Data

  JAMA Network Open · 2025-05-28 · 4 citations

  articleOpen access

  Importance: The test-negative design (TND) has been widely used to assess postmarketing COVID-19 vaccine effectiveness but requires further evaluation for this application. Objective: To determine whether the TND reliably evaluates vaccine effectiveness against symptomatic COVID-19 using placebo-controlled vaccine efficacy randomized clinical trials (RCTs). Design, Setting, and Participants: This secondary cross-protocol analysis constructed TND study datasets from study sites in 16 countries across 5 continents using the blinded phase cohorts of 5 harmonized phase 3 COVID-19 Prevention Network RCTs: COVE (Coronavirus Vaccine Efficacy and Safety), AZD1222, ENSEMBLE, PREVENT-19 (Prefusion Protein Subunit Vaccine Efficacy Novavax Trial COVID-19), and VAT00008. Participants included adults who received the intended number of doses, experienced COVID-19-like symptoms, and obtained SARS-CoV-2 testing. Start dates ranged from July 27, 2020, to October 19, 2021; data cutoff dates ranged from March 26, 2021, to March 15, 2022. Statistical analysis was performed from May 11, 2023, to February 25, 2025. Interventions: Participants received vaccines consisting of messenger RNA-1273 (COVE; 2 doses 28 days apart), ChAdOx1 nCoV-19 (AZD1222; 2 doses 28 days apart), Ad26.COV2.S (ENSEMBLE; 1 dose), NVX-CoV2373 (PREVENT-19; 2 doses 21 days apart), CoV2 preS dTM-AS03 (VAT00008; D614) (2 doses 21 days apart), or CoV2 preS dTM-AS03 (D614 plus B.1.351) (VAT00008; 2 doses 21 days apart) or placebo. Main Outcomes and Measures: Main outcomes were symptomatic COVID-19 according to each trial's primary efficacy definition and the Centers for Disease Control and Prevention definition. Vaccine effectiveness was estimated using targeted maximum likelihood estimation under a semiparametric logistic regression model and ordinary logistic regression. Noncase exchangeability, a core TND assumption for unbiased estimation, was also assessed by estimating vaccine efficacy against non-COVID-19 illness. Results: Among the 12 157 participants included in the analysis, mean (SD) age was 45 (15) years, 6414 were female (53%), 5858 were vaccinated (48%), 2835 experienced primary COVID-19 (23%), and 2992 experienced Centers for Disease Control and Prevention-defined COVID-19 (25%). TND vaccine effectiveness estimates were concordant with RCT vaccine efficacy estimates (concordance correlation coefficient, 0.86 [95% CI, 0.58-0.96] for both outcomes). The semiparametric method had 48% smaller variance estimates than ordinary logistic regression. Noncase exchangeability was generally supported with a median vaccine efficacy against non-COVID-19 illness of 7.7% (IQR, 2.7%-16.8%) across trial cohorts and most 95% CIs including 0. Conclusions and Relevance: In this cross-protocol analysis, the TND provided reliable inferences on COVID-19 vaccine effectiveness in health care-seeking populations for multiple vaccines and symptom definitions when confounding and selection bias were absent. A machine-learning approach for robust confounding control in postmarketing TND studies was also introduced.

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• Immune correlates analysis of antibody responses against SARS-CoV-2 variants in the ENSEMBLE vaccine efficacy trial

  iScience · 2025-10-01 · 1 citations

  articleOpen access

  In Latin American sites of the ENSEMBLE trial of the Ad26.COV2.S vaccine vs. placebo, binding antibodies and neutralizing antibodies measured 4 weeks post-vaccination (∼peak) against circulating lineages (Ancestral, Gamma, Lambda, Mu, Zeta) were assessed as a correlate of risk of, and correlate of protection against, lineage-specific COVID-19. Comparison of lineage-matched controlled vaccine efficacy (VE) curves showed similar relationships across lineages of lineage-specific antibody with VE against lineage-matched COVID-19, supporting a "variant-invariant correlate of protection model" that undergirds immunobridging inferences of efficacy against new variants based on variant-matched neutralizing antibody titers. Lambda departed from this model at undetectable/just-detectable titers: at ∼ peak Reference-specific titers of 2.7 arbitrary units (AU)/mL (just-detectable) and 30 AU/ml, VE against Ancestral COVID-19 was 53.0% (95% CI: 30.7%, 67.9%) and 84.5% (73.6%, 93.0%), respectively; at the same Lambda-specific titers, VE against Lambda COVID-19 was 12.3% (-54.1%, 50.3%) and 91.1% (68.9%, 98.0%). Additional research is needed for Omicron variants.

  PublisherDOI

• Associations between gender and solicited adverse events after passive infusion of VRC01 or placebo in HVTN 704/HPTN 085

  UNC Libraries · 2025-12-17

  articleOpen access

  Background: Realizing the potential of HIV prevention options requires understanding product tolerability across diverse groups vulnerable to HIV acquisition. Gender minority (GM) individuals are understudied in clinical trials. Setting: HVTN 704/HPTN 085, a phase 2b randomized HIV prevention trial, enrolled MSM and transgender participants from Brazil, Peru, Switzerland, and the US to receive an infusion every 8 weeks (10 total) of VRC01 30mg/kg, VRC01 10mg/kg, or placebo. Solicited adverse events (AEs) were recorded for 3 days after each infusion. Methods: Gender was defined by self-report and sex assigned-at-birth. Multivariate mixed logistic models were employed to estimate the association between gender (cisgender men [CM] vs. GM participants [transgender women, transgender men, or another gender]) and solicited AE frequency and severity. Results: GM participants reported more solicited AEs than CM among all participants (adjusted OR 1.59, 95%CI 1.20-2.10, p=0.001) and among placebo recipients (1.72, 1.05-2.81, p=0.031). The severity of solicited AEs (occurrence of ≥Grade 2 event) did not significantly differ overall (1.83, 0.79-4.20, p=0.174) or among placebo recipients (3.05, 0.76-12.32, p=0.112). Grade 2 events were reported after 1% and 2% of total infusions among CM and GM participants, respectively. Grade 3-4 events were rare overall (<0.1%). Completion of 10 infusions was high (78.6%) and slightly higher in CM (79.2%) than GM participants (73%). Conclusion: This is the first report of associations between gender and solicited AEs following monoclonal antibody infusion. GM participants reported more events; severity was low. HIV prevention trials must engage and support GM individuals to best evaluate tolerability of novel agents.

  PublisherDOI

• Referee report. For: Evaluation of the Establishment of a Public and Patient Involvement and Engagement Group to Support Clinical Trials in Pakistan: Protocol for a Mixed-Methods Study [version 1; peer review: 1 approved]

  Faculty of 1000 Research Ltd · 2025-01-01

  peer-reviewOpen access1st authorCorresponding
  PublisherDOI

• Analysis of Antibody Markers as Immune Correlates of Risk of Severe COVID-19 in the PREVENT-19 Efficacy Trial of the NVX-CoV2373 Recombinant Protein Vaccine

  Clinical Infectious Diseases · 2025-10-14 · 1 citations

  articleOpen access

  BACKGROUND: We previously showed that ancestral-specific anti-Spike binding IgG concentration and 50% inhibitory dilution neutralizing antibody titer (nAb-ID50) measured at 2 weeks postdose 2 (∼peak) were inverse correlates of risk (CoRs) of COVID-19 over 2 months post ∼peak in the PREVENT-19 trial of the NVX-CoV2373 vaccine; there were not sufficient data to assess CoRs of severe COVID-19. METHODS: Here, we assessed, in the same vaccinated cohort, Delta- and ancestral-specific Spike IgG and nAb-ID50 at ∼peak and over time as CoRs of severe COVID-19 and of Delta COVID-19 over 3.5-10 months post ∼peak (287 breakthrough Delta cases, including 8 severe; 446 noncases). RESULTS: Peak antibody levels were much higher for noncases versus severe cases (all inferred Delta), with nAb-ID50 Delta geometric mean 209.5 arbitrary units (AU)/mL (95% CI: 176.1, 249.1) versus 9.6 AU/mL (95% CI: 2.4, 38.6), respectively. Frequency of detectable nAb-ID50 titer was 98.3% (97.2, 99.0) for noncases versus 62.5% (22.3, 93.9) for severe cases. All markers were inverse CoRs of severe COVID-19, with a ∼peak hazard ratio (HR) of 0.13 (95% CI: .03, .57) per 10-fold nAb-ID50 Delta increase. Severe COVID-19 risk through 305 days postday 35 was 0.0338 (0.0043, 0.206) at the nAb-ID50 Delta 2.5th percentile (8.4 AU/mL), and 0.002 (0.0000, 0.0108) and 0.0002 (0.0000, 0.0035) at the 50th and 95th percentiles (210, 2522 AU/mL). CONCLUSIONS: Postvaccination NVX-CoV2373 antibody levels are stronger predictors of severe COVID-19 than any-severity Delta COVID-19. Low antibody responses indicate vulnerability to severe COVID-19.

  PublisherDOI

• Rapid development of a registry to accelerate COVID-19 vaccine clinical trials

  npj Digital Medicine · 2025-05-06 · 2 citations

  articleOpen access

  Response to the SARS-Cov-2 pandemic required the unprecedented, rapid activation of the COVID-19 Prevention Network (CoVPN) representing hundreds of sites conducting vaccine clinical trials. The CoVPN Volunteer Screening Registry (VSR) collected participant information, distributed qualified candidates across sites, and monitored enrollment progress. The system consisted of three web-based interfaces. The Volunteer Questionnaire flowed into a secure database. The Site Portal supported volunteer selection, analytics, and enrollment. The Administrative Portal enabled dynamic analytic reports by geography, clinical trial, and site, including volunteering rates over time. The VSR collected over 650,000 volunteers, serving a key role in the recruitment of diverse participants for multiple Phase 3 clinical trials. Over 47% of the 166,729 volunteers selected for screening represented prioritized groups. The success of the VSR demonstrates how digital tools can be rapidly yet safely integrated into an accelerated clinical trial setting. We summarize the development of the system and lessons learned for pandemic preparedness.

  PublisherOA PDFDOI

• Brief Report: Associations Between Gender and Solicited Adverse Events After Passive Infusion of VRC01 or Placebo in HVTN 704/HPTN 085

  JAIDS Journal of Acquired Immune Deficiency Syndromes · 2024-12-16

  articleOpen access

  BACKGROUND: Realizing the potential of HIV prevention options requires understanding product tolerability across diverse groups vulnerable to HIV acquisition. Gender minority (GM) individuals are understudied in clinical trials. SETTING: HVTN 704/HIV Prevention Trials Network 085, a phase 2b randomized HIV prevention trial, enrolled MSM and transgender participants from Brazil, Peru, Switzerland, and the United States to receive an infusion every 8 weeks (10 total) of VRC01 30 mg/kg, VRC01 10 mg/kg, or placebo. Solicited adverse events (AEs) were recorded for 3 days after each infusion. METHODS: Gender was defined by self-report and sex assigned-at-birth. Multivariate mixed logistic models were used to estimate the association between gender (cisgender men [CM] vs. GM participants [transgender women, transgender men, or another gender]) and solicited AE frequency and severity. RESULTS: GM participants reported more solicited AEs than CM among all participants (adjusted OR 1.59, 95% CI: 1.20 to 2.10, P = 0.001) and among placebo recipients (1.72, 1.05 to 2.81, P = 0.031). The severity of solicited AEs (occurrence of grade 2 and higher event) did not significantly differ overall (1.83, 0.79 to 4.20, P = 0.174) or among placebo recipients (3.05, 0.76 to 12.32, P = 0.112). Grade 2 events were reported after 1% and 2% of total infusions among CM and GM participants, respectively. Grade 3-4 events were rare overall (<0.1%). Completion of 10 infusions was high (78.6%) and slightly higher in CM (79.2%) than GM participants (73%). CONCLUSIONS: This is the first report of associations between gender and solicited AEs after monoclonal antibody infusion. GM participants reported more events; severity was low. HIV prevention trials must engage and support GM individuals to best evaluate tolerability of novel agents.

  PublisherOA PDFDOI

• Omicron COVID-19 immune correlates analysis of a third dose of mRNA-1273 in the COVE trial

  Nature Communications · 2024-09-11 · 7 citations

  articleOpen access

  In the phase 3 Coronavirus Efficacy (COVE) trial (NCT04470427), post-dose two Ancestral Spike-specific binding (bAb) and neutralizing (nAb) antibodies were shown to be correlates of risk (CoR) and of protection against Ancestral-lineage COVID-19 in SARS-CoV-2 naive participants. In the SARS-CoV-2 Omicron era, Omicron subvariants with varying degrees of immune escape now dominate, seropositivity rates are high, and booster doses are administered, raising questions on whether and how these developments affect the bAb and nAb correlates. To address these questions, we assess post-boost BA.1 Spike-specific bAbs and nAbs as CoRs and as correlates of booster efficacy in COVE. For naive individuals, bAbs and nAbs inversely correlate with Omicron COVID-19: hazard ratios (HR) per 10-fold marker increase (95% confidence interval) are 0.16 (0.03, 0.79) and 0.31 (0.10, 0.96), respectively. In non-naive individuals the analogous results are similar: 0.15 (0.04, 0.63) and 0.28 (0.07, 1.08). For naive individuals, three vs two-dose booster efficacy correlates with predicted nAb titer at exposure, with estimates -8% (-126%, 48%), 50% (25%, 67%), and 74% (49%, 87%), at 56, 251, and 891 Arbitrary Units/ml. These results support the continued use of antibody as a surrogate endpoint.

  PublisherOA PDFDOI

Recent grants

• NIH Grant R21HD057832

  NIH · $640k · 2012

Frequent coauthors

• Lawrence Corey

  Fred Hutch Cancer Center

  55 shared

• Peter B. Gilbert

  Fred Hutch Cancer Center

  54 shared

• James G. Kublin

  Fred Hutch Cancer Center

  53 shared

• Glenda Gray

  South African Medical Research Council

  37 shared

• Dean Follmann

  National Institute of Allergy and Infectious Diseases

  35 shared

• Holly Janes

  Fred Hutch Cancer Center

  34 shared

• Youyi Fong

  Fred Hutch Cancer Center

  31 shared

• Chenchen Yu

  Fred Hutch Cancer Center

  29 shared