Participation In Vaccine Research Research Articles

Pregnant women's perceptions of risks and benefits when considering participation in vaccine trials

IntroductionDespite historical exclusion, there has been recent recognition of the need to address the health of pregnant women in research on vaccines against emerging pathogens. However, pregnant women’s views and decision-making processes about vaccine research participation during infectious disease outbreaks remain underexplored. This study aims to examine women’s decision-making processes around vaccine research participation during infectious disease outbreaks. MethodsWe conducted qualitative semi-structured in-depth interviews with pregnant and recently pregnant women (n = 13), eliciting their views on four hypothetical Zika Virus vaccine research scenarios and probing their decision-making processes around participation. After recorded interviews were transcribed, thematic analysis was conducted based on a priori and emergent themes. ResultsMost women interviewed were accepting of vaccine research scenarios. Three broad themes—evidence, risk, and trust—characterized women’s decision-making processes. Women varied in how different types and levels of evidence impacted their considerations, which risks were most salient to their decision-making processes, and from whom they trusted recommendations about vaccine research participation. Exemplary quotes from each theme are presented, and lessons for vaccine development during the current COVID-19 pandemic and future outbreaks are discussed. ConclusionSome pregnant women are accepting of participation in vaccine research during infectious disease outbreaks. Incorporating their priorities into trial design may facilitate their participation and generation of evidence for this important population.

Pregnant women’s attitudes toward Zika virus vaccine trial participation

IntroductionAs Zika virus infection during pregnancy can cause a range of congenital anomalies, pregnant women may be a target population for vaccination in future outbreaks. Their inclusion in vaccine trials is critical to ensure safe and effective vaccines in pregnancy. Though many vaccine candidates are in development, pregnant women’s willingness to participate in Zika virus vaccine research is unknown. This study aims to describe pregnant women’s attitudes toward Zika virus vaccine research participation, as well as perceived barriers to and facilitators of enrollment. MethodsPregnant and recently postpartum women (n = 128) attending prenatal care at Massachusetts General Hospital completed surveys querying their willingness to participate in four hypothetical Zika virus vaccine trials and their motivations for participation. Demographics, information on prior Zika virus exposure, and vaccine acceptance were collected. ResultsMost women (77%) accepted participation in at least one hypothetical Zika virus vaccine trial, and women were significantly more likely to accept prospective enrollment in an inactivated vaccine trial compared to a live-attenuated vaccine trial (p-value <0.0001) or a nucleic acid-based vaccine trial (p-value <0.0444). Important motivators for participation included evidence from research with pregnant and non-pregnant people, a desire to protect the baby from Zika, perceptions of vaccine safety, and provider recommendation. ConclusionsA majority of women in this cohort were willing to participate in a Zika virus vaccine trial while pregnant, however, differences in acceptance exist between vaccine platforms. The high value placed on evidence by participants highlights the importance of gathering and communicating pregnancy-specific data to potential research participants and their providers. Women’s motivations for accepting research participation during pregnancy are important to inform the Zika virus vaccine research agenda, candidate prioritization, and trial design.

Racial/Ethnic Differences in Trust in Health Care: HIV Conspiracy Beliefs and Vaccine Research Participation

Prior research has documented a high prevalence of conspiracy beliefs about the origin of the human immunodeficiency virus (HIV) and the role of the government in the acquired immunodeficiency syndrome (AIDS) epidemic, particularly among racial and ethnic minorities in the United States. Whether such beliefs are a barrier to participation in HIV prevention research is not known. To understand the prevalence of HIV conspiracy beliefs and their relationship to willingness to participate in HIV vaccine research among three racial/ethnic groups. Cross-sectional survey. Six hundred and one community-recruited volunteers (33.0 % White, 32.5 % Mexican American, and 34.5 % African American). We evaluated the level of agreement with six previously described HIV conspiracy beliefs, trust in medical research, and willingness to participate in HIV vaccine research. Multivariate models were used to compare these parameters among the three racial/ethnic groups while controlling for the potential confounding effects of socioeconomic status, access to health care, and other demographic factors. African Americans, Mexican Americans, and whites had similar levels of distrust in medical research. African and Mexican Americans were more likely to endorse one or more of six HIV conspiracy beliefs than whites (59.0 % and 58.6 % versus 38.9 %, respectively, P < 0.001), but were significantly more willing to participate in HIV vaccine research (ORs 1.58, CI 1.10-2.25 and 2.53, CI 1.75-3.66, respectively). Among respondents of all racial/ethnic groups, endorsing HIV conspiracy beliefs was not associated with willingness to participate in research. HIV conspiracy beliefs, while common among all racial and ethnic groups in the United States, do not preclude willingness to participate in HIV prevention research.

“Once I begin to participate, people will run away from me”: Understanding stigma as a barrier to HIV vaccine research participation in Kenya

Participation of volunteers in clinical research is essential to the development of effective HIV prevention methods, including an HIV vaccine. This study expands current knowledge of stigma and discrimination related to participation in HIV vaccine research in sub-Saharan Africa by exploring the perception of stigma and discrimination as a barrier to participation in HIV vaccine research in Kenya. Eighteen focus groups with a total of 133 participants and 82 individual interviews were conducted with a range of respondents at two centers in Nairobi, Kenya: a preventive AIDS vaccine trial center; and a preparatory clinical and epidemiological study center. Respondents included peer leaders, community advisory board members, former and current volunteers in clinical research, study staff, community leaders and community members. Data were analyzed using an iterative coding process. Four prominent stigma-related barriers to participation emerged among all respondent groups, across both centers: (1) volunteers are often assumed by family and community members to be HIV positive because of their participation in vaccine research; (2) HIV-related stigma is perceived as pervasive and damaging in the communities where volunteers live, thus they fear consequent stigma if people believe them to be HIV positive; (3) potential volunteers fear being tested for HIV, a prerequisite for participation, because of possible disclosure of HIV status in communities with high perceived HIV-related stigma; and (4) volunteers must carefully manage information about their participation because of misperceptions and assumptions about vaccine research volunteers. HIV-related stigma and discrimination influence people's decisions to join HIV-vaccine related research. Findings underscore a need for integration of stigma-reduction programming into education and outreach activities for volunteers, and the communities in which they live. This is particularly critical for trials recruiting individuals with higher HIV risk, who are often already highly stigmatized.

Socioecological influences on community involvement in HIV vaccine research

Objective This study investigated socioecological factors influencing HIV vaccine research participation among communities living in geographic areas with high HIV prevalence and high poverty rates. Methods We surveyed a sample of 453 adults ≤18 years from areas of high poverty and high HIV prevalence in metro Atlanta and differentiated the effects of individual-, social/organizational-, and community-level characteristics on participation in HIV vaccine research via multilevel modeling techniques that incorporated questionnaire, program, and census data. Results Models that adjusted for both individual-level covariates (such as race, gender, attitudes, and beliefs concerning HIV research), social/organizational- and community-level factors such as local HIV prevalence rates, revealed that the extent of HIV prevention-related programs and services in census tracts contributed to individuals’ likelihood of participation in an HIV vaccine study. Additionally, neighborhood-based organizations offering HIV medical and treatment programs, support groups, and services (e.g., food, shelter, and clothing) encourage greater HIV vaccine research participation. Conclusions The findings support the hypothesis that community-level factors facilitate participation in HIV vaccine research independent of both individual- and social/organizational-level factors.

Selectively willing and conditionally able: HIV vaccine trial participation among women at “high risk” of HIV infection

Efficacy studies of investigational HIV vaccines require enrollment of individuals at ‘high risk’ for HIV. This paper examines participation in HIV vaccine trials among women at ‘high risk’ for HIV acquisition. In-depth interviews were conducted with 17 African-American women who use crack cocaine and/or exchange sex for money/drugs to elicit attitudes toward medical research and motivators and deterrents to HIV vaccine trial participation. Interviews were digitally recorded and transcribed; data were coded and compiled into themes. Most women expressed favorable attitudes toward medical research in general. Motivators for trial participation included compensation; personal benefits including information, social services, and the possibility that the trial vaccine could prevent HIV; and altruism. Deterrents included: dislike of needles; distrust; concern about future consequences of participating. In addition, contingencies, care-giving responsibilities, and convenience issues constituted barriers which could impede participation. Respondents described varied, complex perspectives, and individual cases illustrate how these themes played out as women contemplated trial participation. Understanding factors which influence vaccine research participation among women at ‘high risk’ can aid sites to tailor recruitment procedures to local contexts. Concerns about future reactions can be addressed through sustained community education. Convenience barriers can be ameliorated by providing rides to study visits when necessary, and/or conducting study visits in accessible neighborhood locations. Women in this sample thought carefully about enrolling in HIV vaccine trials given the structural constraints within which they lived. Further research is needed regarding structural factors which influence personal agency and individuals’ thinking about research participation.

Children’s participation in vaccine research: parents’ views

Children’s participation in vaccine research: parents’ views

Children’s participation in vaccine research: parents’ views

Vaccine studies that evaluate the persistence of protection following immunisation require subjects to continue participation in a research protocol over many years. As parents' attitudes and opinions may change over time, and with experience of research, it is important to consider the factors influencing parents' decision-making about their child's continued participation in such prolonged vaccine studies. Parental views about participation of their child in a one-year follow-up vaccine study were explored by means of a self-administered questionnaire. Of the 254 eligible parents, 187 took part (74 per cent). Parents who provided consent were more likely to agree that having a home visit to take blood was very helpful (p=0.005) and that information obtained during the earlier part of the study influenced their decision to take part in a follow-up study (p<0.0001). Parents who did not consent to their child's participation were more likely to report the presence of personal reasons as a variable influencing their decision (p<0.0001). The relationship between study staff and parents is the cornerstone for success in performing studies involving vaccines and children. Provision of clear study information (oral and written) and offering the convenience of home visits are important in retaining participants in paediatric vaccine trials.

The Role Familiarity With Science and Medicine Plays in Parents’ Decision Making About Enrolling a Child in Vaccine Research

Parental consent to children's participation in vaccine research has resulted in the licensure of essential vaccines. Recruitment to this type of research is typically difficult, however, and many parents decline. In this study, the authors interviewed parents about their decision for or against enrolling their child in a vaccine study. The data analysis suggests that parents' ability to evaluate a vaccine study depends on how attuned they are with science and medicine, either professionally or as consumers of health services. Familiarity does not predispose parents to enrolling their child in research; rather, it is a predictor of parents' confidence in their decision making. Many parents were motivated by altruism and trust, which, if uninformed, can leave the parents prone to exploitation. It is vital to ensure that parents are confident in their judgment of a study and its potential benefit to their child and society.