RANDOMIZED CONTROL TRIALS:
ROLE OF CLINICAL TRIALS IN THE
REDUCTION OF VACCINE
HESITANCY IN NIGERIA
Outline
• Introduction
• Understanding Vaccine Hesitancy
• The Importance of Vaccines in Public Health
• Overview of Randomized Controlled Trials
• RCTs Relevant to Vaccination
• Clinical Trials in Nigeria – Historical Context
• Role of RCTs in Reducing Vaccine Hesitancy
• Evidence from Recent Clinical Trials
• Case Study: MenAfriVac Trials
• Challenges in Using RCTs to Address Hesitancy
• Recommendations
• Conclusion
Introduction
• Vaccine hesitancy is a significant
public health challenge globally and in
Nigeria (Ibekwe et al., 2024)
• Randomized Controlled Trials (RCTs)
provide evidence-based strategies to
address public mistrust.
• This presentation explores how
clinical trials, especially RCTs,
contribute to vaccine acceptance and
uptake in Nigeria.
Understanding
Vaccine Hesitancy
• Defined by WHO as the delay in
acceptance or refusal of
vaccines despite availability.
• Influenced factors including:
• Misinformation
• cultural beliefs
• mistrust in health systems
• Complacency
• High prevalence in Northern
Nigeria due to historical,
religious, and socio-political
factors.
The Importance of Vaccines in Public
Health
• Impact of vaccines on
reducing infectious diseases.
• The role of vaccination in
controlling outbreaks
• Polio
• measles
Overview of Randomized Controlled Trials
• RCTs: gold standard for testing the
efficacy of medical intervention in clinical
research.
• Participants are randomly assigned to
intervention or control groups.
• Reduce bias and establish causal
relationships.
RCTs Relevant to Vaccination
• Individually Randomized Trials
• Cluster-Randomized Trials
• Stepped-Wedge Designs
• Used to evaluate vaccine effectiveness,
safety, and community perceptions.
Clinical Trials in Nigeria – Historical Context
• Nigeria has hosted major vaccine trials
(e.g., MenAfriVac, COVID-19 vaccine
trials).
• Past controversies (e.g., Pfizer 1996
Trovan trial) influenced public trust
(Lenzer, 2006)
• Rebuilding trust through transparency
and community engagement.
Role of RCTs in Reducing Vaccine Hesitancy
• Provide reliable data on vaccine safety
and effectiveness.
• RCTs in community settings foster
transparency and inclusion.
• Educate the public and healthcare
workers, increasing confidence.
Evidence from Recent Clinical Trials
• COVID-19 vaccine trials: involved
Nigerian participants. E.g., Oxford-
AstraZeneca (Eguavoen et al., 2023)
• Result: increased vaccine confidence
post-trials in some urban communities.
• Community-based education during RCTs
improved acceptance.
Case Study: MenAfriVac Trials
• Conducted in Nigeria and other West
African countries (Borrow et al., 2015).
• Demonstrated high efficacy and
community engagement strategies.
• Helped reduce meningitis A and
improved perception of vaccines.
Challenges in Using RCTs
to Address Hesitancy
• Ethical concerns in low-resource
settings.
• Mistrust due to historical
exploitation.
• Limited awareness of clinical
trial processes.
• Inadequate representation of
rural communities.
Recommendations
• Strengthen community
engagement in trial design and
implementation.
• Promote public education on the
role of RCTs in health improvement.
• Collaborate with local leaders to
dispel myths.
• Ensure equitable inclusion in
clinical trials.
Conclusion
• RCTs are vital tools in building public trust and
demonstrating vaccine safety and efficacy.
• In Nigeria, well-conducted clinical trials have helped dispel
myths and foster community acceptance, especially when
paired with effective engagement and education strategies.
• Despite historical challenges, the integration of transparent,
inclusive, and ethically grounded RCTs can play a key role in
reducing vaccine hesitancy.
• Going forward, policy makers, researchers, and community
leaders must collaborate to leverage RCTs as both scientific
and social instruments in strengthening immunization
programs.
References
1. Ibekwe, J.L., Femi-Lawal, V.O., Thomas, J.A. Okei, F.U., Ojile, M.O. and Akingbulugbe, O.O. (2024).
2. Lenzer, J. (2006). Secret report surfaces showing that Pfizer was at fault in Nigerian drug tests. BMJ.
332(7552):1233. doi: 10.1136/bmj.332.7552.1233-a
3. Nigerians’ attitudes and perceptions towards vaccine acceptance during and after the COVID-19 pandemic.
Journal of Medicine, Surgery, and Public Health. 2:100066. https://doi.org/10.1016/j.glmedi.2024.100066
4. Afolabi, A., & Ilesanmi, O. (2021). COVID-19 vaccine hesitancy in Nigeria: A call for action. The Pan African
Medical Journal, 38, 109. https://doi.org/10.11604/pamj.2021.38.109.28953
5. Dada, D., Djiometio, J. N., McFadden, S. M., Demeke, J., Vlahov, D., Wilton, L., & Nelson, L. E. (2022). Strategies
that promote equity in COVID-19 vaccine uptake for Black communities: a review. Journal of Urban Health,
99(1), 15-27.
6. Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of
Clinical Trials (5th ed.). Springer.
7. Harry, A.M.,Edet, C.K., Ekanem, N.F., Kemdirim, C.J. and Uduak, A.E. (2022). Adverse Events Following COVID-
19 Vaccination in Rivers State, Nigeria A Cross-Sectional Study. Nigerian Postgraduate Medical Journal
29(2):89-95. DOI: 10.4103/npmj.npmj_11_22
8. Eguavoen, A., Larson, H.J., Chinye-Nwoko, F. and Ojeniyi, T. (2023). Reducing COVID-19 vaccine hesitancy and
improving vaccine uptake in Nigeria. J Public Health Afr . 14(5):2290. doi: 10.4081/jphia.2023.2290.
References
9. Jegede, A. S. (2007). What led to the Nigerian boycott of the polio vaccination campaign? PLoS Medicine, 4(3),
e73.
10. Borrow, R., Tang, Y., Yakubu, A., Kulkarni, P.S. and LaForce, F.M. (2015). MenAfriVac as an Antitetanus Vaccine.
Clin Infect Dis. 2015 Nov 9;61(Suppl 5):S570–S577. doi: 10.1093/cid/civ512
11. LaForce, F. M., Konde, K., Viviani, S., & Preziosi, M. P. (2015). The Meningitis Vaccine Project. Vaccine, 33, B1-
B3.
12. MacDonald, N. E. (2015). Vaccine hesitancy: Definition, scope and determinants. Vaccine, 33(34), 4161–4164.
13. Okonta, P. I. (2014). Ethics of clinical trials in Nigeria. Nigerian Journal of Clinical Practice, 17(3), 291–296.
14. Tindana, P. O., Kass, N., & Akweongo, P. (2007). The informed consent process in a rural African setting. BMC
Medical Ethics, 8, 12.
15. World Health Organization. (2021). Vaccine hesitancy: A growing challenge for immunization programmes.
https://www.who.int/news/item/18-08-2015-vaccine-hesitancy-a-growing-challenge-for-immunization-progra
mmes
Accessed April 24 2025
16. Hayes, R. J., & Moulton, L. H. (2017). Cluster Randomised Trials (2nd ed.). CRC Press.

Randomized Control Trial: Role in reducing vaccine hesitancy in Nigeria.pptx

  • 1.
    RANDOMIZED CONTROL TRIALS: ROLEOF CLINICAL TRIALS IN THE REDUCTION OF VACCINE HESITANCY IN NIGERIA
  • 2.
    Outline • Introduction • UnderstandingVaccine Hesitancy • The Importance of Vaccines in Public Health • Overview of Randomized Controlled Trials • RCTs Relevant to Vaccination • Clinical Trials in Nigeria – Historical Context • Role of RCTs in Reducing Vaccine Hesitancy • Evidence from Recent Clinical Trials • Case Study: MenAfriVac Trials • Challenges in Using RCTs to Address Hesitancy • Recommendations • Conclusion
  • 3.
    Introduction • Vaccine hesitancyis a significant public health challenge globally and in Nigeria (Ibekwe et al., 2024) • Randomized Controlled Trials (RCTs) provide evidence-based strategies to address public mistrust. • This presentation explores how clinical trials, especially RCTs, contribute to vaccine acceptance and uptake in Nigeria.
  • 4.
    Understanding Vaccine Hesitancy • Definedby WHO as the delay in acceptance or refusal of vaccines despite availability. • Influenced factors including: • Misinformation • cultural beliefs • mistrust in health systems • Complacency • High prevalence in Northern Nigeria due to historical, religious, and socio-political factors.
  • 5.
    The Importance ofVaccines in Public Health • Impact of vaccines on reducing infectious diseases. • The role of vaccination in controlling outbreaks • Polio • measles
  • 6.
    Overview of RandomizedControlled Trials • RCTs: gold standard for testing the efficacy of medical intervention in clinical research. • Participants are randomly assigned to intervention or control groups. • Reduce bias and establish causal relationships.
  • 7.
    RCTs Relevant toVaccination • Individually Randomized Trials • Cluster-Randomized Trials • Stepped-Wedge Designs • Used to evaluate vaccine effectiveness, safety, and community perceptions.
  • 8.
    Clinical Trials inNigeria – Historical Context • Nigeria has hosted major vaccine trials (e.g., MenAfriVac, COVID-19 vaccine trials). • Past controversies (e.g., Pfizer 1996 Trovan trial) influenced public trust (Lenzer, 2006) • Rebuilding trust through transparency and community engagement.
  • 9.
    Role of RCTsin Reducing Vaccine Hesitancy • Provide reliable data on vaccine safety and effectiveness. • RCTs in community settings foster transparency and inclusion. • Educate the public and healthcare workers, increasing confidence.
  • 10.
    Evidence from RecentClinical Trials • COVID-19 vaccine trials: involved Nigerian participants. E.g., Oxford- AstraZeneca (Eguavoen et al., 2023) • Result: increased vaccine confidence post-trials in some urban communities. • Community-based education during RCTs improved acceptance.
  • 11.
    Case Study: MenAfriVacTrials • Conducted in Nigeria and other West African countries (Borrow et al., 2015). • Demonstrated high efficacy and community engagement strategies. • Helped reduce meningitis A and improved perception of vaccines.
  • 12.
    Challenges in UsingRCTs to Address Hesitancy • Ethical concerns in low-resource settings. • Mistrust due to historical exploitation. • Limited awareness of clinical trial processes. • Inadequate representation of rural communities.
  • 13.
    Recommendations • Strengthen community engagementin trial design and implementation. • Promote public education on the role of RCTs in health improvement. • Collaborate with local leaders to dispel myths. • Ensure equitable inclusion in clinical trials.
  • 14.
    Conclusion • RCTs arevital tools in building public trust and demonstrating vaccine safety and efficacy. • In Nigeria, well-conducted clinical trials have helped dispel myths and foster community acceptance, especially when paired with effective engagement and education strategies. • Despite historical challenges, the integration of transparent, inclusive, and ethically grounded RCTs can play a key role in reducing vaccine hesitancy. • Going forward, policy makers, researchers, and community leaders must collaborate to leverage RCTs as both scientific and social instruments in strengthening immunization programs.
  • 15.
    References 1. Ibekwe, J.L.,Femi-Lawal, V.O., Thomas, J.A. Okei, F.U., Ojile, M.O. and Akingbulugbe, O.O. (2024). 2. Lenzer, J. (2006). Secret report surfaces showing that Pfizer was at fault in Nigerian drug tests. BMJ. 332(7552):1233. doi: 10.1136/bmj.332.7552.1233-a 3. Nigerians’ attitudes and perceptions towards vaccine acceptance during and after the COVID-19 pandemic. Journal of Medicine, Surgery, and Public Health. 2:100066. https://doi.org/10.1016/j.glmedi.2024.100066 4. Afolabi, A., & Ilesanmi, O. (2021). COVID-19 vaccine hesitancy in Nigeria: A call for action. The Pan African Medical Journal, 38, 109. https://doi.org/10.11604/pamj.2021.38.109.28953 5. Dada, D., Djiometio, J. N., McFadden, S. M., Demeke, J., Vlahov, D., Wilton, L., & Nelson, L. E. (2022). Strategies that promote equity in COVID-19 vaccine uptake for Black communities: a review. Journal of Urban Health, 99(1), 15-27. 6. Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. 7. Harry, A.M.,Edet, C.K., Ekanem, N.F., Kemdirim, C.J. and Uduak, A.E. (2022). Adverse Events Following COVID- 19 Vaccination in Rivers State, Nigeria A Cross-Sectional Study. Nigerian Postgraduate Medical Journal 29(2):89-95. DOI: 10.4103/npmj.npmj_11_22 8. Eguavoen, A., Larson, H.J., Chinye-Nwoko, F. and Ojeniyi, T. (2023). Reducing COVID-19 vaccine hesitancy and improving vaccine uptake in Nigeria. J Public Health Afr . 14(5):2290. doi: 10.4081/jphia.2023.2290.
  • 16.
    References 9. Jegede, A.S. (2007). What led to the Nigerian boycott of the polio vaccination campaign? PLoS Medicine, 4(3), e73. 10. Borrow, R., Tang, Y., Yakubu, A., Kulkarni, P.S. and LaForce, F.M. (2015). MenAfriVac as an Antitetanus Vaccine. Clin Infect Dis. 2015 Nov 9;61(Suppl 5):S570–S577. doi: 10.1093/cid/civ512 11. LaForce, F. M., Konde, K., Viviani, S., & Preziosi, M. P. (2015). The Meningitis Vaccine Project. Vaccine, 33, B1- B3. 12. MacDonald, N. E. (2015). Vaccine hesitancy: Definition, scope and determinants. Vaccine, 33(34), 4161–4164. 13. Okonta, P. I. (2014). Ethics of clinical trials in Nigeria. Nigerian Journal of Clinical Practice, 17(3), 291–296. 14. Tindana, P. O., Kass, N., & Akweongo, P. (2007). The informed consent process in a rural African setting. BMC Medical Ethics, 8, 12. 15. World Health Organization. (2021). Vaccine hesitancy: A growing challenge for immunization programmes. https://www.who.int/news/item/18-08-2015-vaccine-hesitancy-a-growing-challenge-for-immunization-progra mmes Accessed April 24 2025 16. Hayes, R. J., & Moulton, L. H. (2017). Cluster Randomised Trials (2nd ed.). CRC Press.