CISM STRENGTHENS COMMITMENT TO WOMEN’S HEALTH THROUGH CLINICAL TRIAL ON THE HPV VACCINE

The initiative aims to evaluate the immunogenicity, safety, and tolerability of the CERVAVAC vaccine

In the context of the celebrations of the International Clinical Trials Day, marked on May 20, and the International Day of Action for Women’s Health, celebrated on May 28, the Centro de Investigação em Saúde de Manhiça (CISM) highlights an important clinical trial evaluating the safety and efficacy of the vaccine against the Human Papillomavirus (HPV) in women living with HIV in Mozambique. The initiative aims to assess the immunogenicity, safety, and tolerability of the CERVAVAC vaccine, comparing it to the Gardasil vaccine, which is already internationally used in the prevention of HPV-related diseases.

The multicenter clinical trial SII-qHPV/MC-03, which evaluates the CERVAVAC® vaccine (marketed by Serum Institute of India Pvt. Ltd.), is being conducted in South Africa, Kenya, and Mozambique. In Mozambique, the study is being implemented by the Centro de Investigação em Saúde de Manhiça (CISM), under the leadership of Principal Investigator Tacilta Nhampossa.

The study involves women aged 15 to 25 years and aims to recruit around 150 Mozambican participants, out of a total of 450 women enrolled across the three countries. This initiative reinforces the importance of HPV vaccination, the main primary prevention strategy against cervical cancer, one of the leading causes of cancer-related mortality among women in Sub-Saharan Africa. Since HPV infection is often asymptomatic and natural immunity is limited, prophylactic vaccines represent an essential tool to reduce the burden of the disease and contribute to the elimination of cervical cance

Women’s Health: A Priority Challenge in Mozambique

The International Day of Action for Women’s Health was established in 1987 during the 5th International Women and Health Meeting, held in Costa Rica. The date aims to raise awareness among governments, institutions, and communities about the challenges women face in accessing healthcare, including sexual and reproductive health, disease prevention, access to information, and quality healthcare services.

In Mozambique, cervical cancer remains one of the leading causes of cancer-related deaths among women and is strongly associated with HIV infection. HIV weakens the immune system, making it more difficult to eliminate HPV, which increases the risk of developing precancerous lesions and progression to invasive cancer.

The CERVAVAC vaccine aims to prevent HPV-related diseases, including: cervical cancer; vulvar, vaginal, and anal cancer; genital warts; and cervical, vaginal, and anal precancerous lesions caused by HPV types 6, 11, 16, and 18.

The research represents an important advancement for public health, particularly because it focuses on women living with HIV, a group that is often more vulnerable to complications associated with HPV.

Clinical Trials Aimed at Improving Women’s Health

The International Clinical Trials Day, celebrated on May 20, highlights the fundamental role of scientific research in the development of vaccines, medicines, and new public health approaches. The date honors the first documented clinical trial in modern history, conducted in 1747 by the Scottish physician James Lind, who is considered a pioneer of clinical research.

In the SII-qHPV/MC-03 study, participants are followed for 12 months, undergoing medical consultations, physical examinations, laboratory tests, HIV viral load monitoring, CD4 count assessments, and immunological analyses to evaluate the body’s response to the vaccine. The protocol includes the administration of two or three doses of the vaccine; continuous clinical follow-up; monitoring of possible side effects; and evaluation of antibody production against HPV.

The study reinforces the importance of scientific research focused on the needs of Mozambican women and on strengthening sustainable solutions to the country’s public health challenges.

Science, Inclusion, and Impact

The inclusion of women in clinical research is essential to improving women’s health, as it allows for the generation of evidence that is better suited to their needs. Participation in studies helps to better understand the diseases that affect women and to develop more effective and safer prevention, diagnosis, and treatment strategies.

In addition to contributing to international scientific development, the study may generate relevant evidence for future vaccination strategies and public policies aimed at preventing cervical cancer in Mozambique and across Africa.

According to Dr. Tacilta Nhampossa, “the trial reaffirms the commitment of the Centro de Investigação em Saúde de Manhiça (CISM) to promoting women’s health, scientific research, and the development of solutions that help reduce the impact of preventable diseases in the country.”

According to the researcher, clinical studies such as this are essential to ensure that vaccines and treatments are safe, effective, and adapted to the epidemiological realities of African populations. In addition, they contribute to strengthening national scientific capacity and expanding access to health innovations.