Executive Summary : | scientists from I.I.sc. Bangalore, PGIMER Chandigarh, and sastra University, Tamil Nadu Thanjavur, have developed hollow stainless-steel microneedles for administering routine childhood vaccinations. These microneedles have shown safety, efficacy, and immunogenicity in preliminary studies in rats and guinea pigs. The researchers hypothesize that microneedle injections will be more efficacious, safe, better tolerated, and cost-effective for delivering vaccines compared to conventional hypodermic needles. The project aims to evaluate the feasibility of delivering vaccines to infants using microneedles in a step-wise manner. Animal experiments will establish the safety, efficacy, and immunogenicity of intradermal administration of vaccines, followed by evaluating reduced dosages. Clinical trials will be initiated in humans in an age-de-escalating manner, starting with adults, adolescents, children, and infants. Pre-clinical testing in mice will study the immunogenic response to intradermal administration of Pentavalent vaccine (standard dose and reduced dose) using the microneedle system compared to intramuscular administration and conventional hypodermic needles. Clinical testing in humans will evaluate the safety, immunogenicity, and pain response of intradermal administration of age-appropriate vaccines using microneedles, comparing them to conventional intramuscular injections and hypodermic needles. The project's importance lies in its enhanced safety, efficacy, and minimal pain compared to conventional routes of administration, as well as its potential for cost savings in vaccine dosage, storage, cold chain, and transport. |