India: Phase-2 trials of world's first one-shot pneumococcal vaccine soon
India is set to begin the phase-2 trials of the world's first one-shot pneumococcal vaccine for adults soon. Manufactured by Hyderabad-based Biological E, the phase-2 trials of the vaccine are likely to begin in July, involving 250 participants. Phase-1 trials were concluded earlier this year. To note, pneumococcal vaccines are usually administered in two shots for adults and four shots for children.
- Pneumococcal vaccines protect against bacteria that cause pneumococcal diseases such as bacteremia, bacterial pneumonia, and meningitis.
- Any infection caused by bacteria called Streptococcus pneumoniae, or pneumococcus, is called pneumococcal disease.
- Pneumococcal diseases are broadly classified into invasive and non-invasive (mucosal) forms.
- Notably, as per a study, India has the highest mortality and morbidity due to invasive pneumococcal disease among adults aged above 50 years.
The phase-1 trials of the investigational vaccine candidate were conducted earlier this year to assess the safety, reactogenicity, tolerability, and immunogenicity of a single intramuscular dose in healthy adults aged 18-45 years. There were reportedly 60 participants in the trials, which were held only at one trial site in the country. The duration of the phase-1 trials was 35 days for each participant.
As per the trial protocol synopsis submitted to drug regulator CDSCO, Biological E's candidate "pneumococcal polysaccharide conjugate vaccine (24Valent)" could provide serotype protection of over 85% in India. This is because it includes the most prevalent serotypes in India. The most prevalent serotypes in India reportedly include 14, 5, 1, 19F, 6B, 6A, 19A, 23F, 22F, 3, 9V, 18C, 4, 7F, 33F, and 17.1.
The protocol synopsis also highlighted the importance of evaluating circulating serotypes in a particular country to select a "suitable vaccine to ensure maximum efficacy and cost‐effectiveness." Citing a recent study in India, it said, "54% of the pneumococcal isolates belonged to PCV‐10 and 73% to PCV‐13." Biological E's vaccine contains polysaccharides from PCV13's 13 serotypes and 11 additional serotypes specific to India, it added.