Assessing the Efficacy and Immunogenicity of Anticaries Vaccine-A Systematic Review and Meta-Analysis.
Kumar Gunjan, Dash Payal, Nanda Smruti Bhusan, et al. · Immunity, inflammation and disease · 2025 · PubMed · doi:10.1002/iid3.70253
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Animal models (nonhuman primates, rodents) or plant-based/transgenic systems evaluating anticaries vaccines targeting Streptococcus mutans | 17 preclinical studies: BALB/c and Sprague-Dawley mice, Wistar and Sprague-Dawley rats, hamsters, and one transgenic tomato; mostly S. mutans challenged rodents (n=17) |
| Intervention | Anticaries vaccines (recombinant, plant-based, or DNA vaccines) targeting S. mutans; adjuvants and antibodies (passive immunization) also eligible | Anticaries vaccines across platforms: DNA vaccines (pGJA-P/VAX, pGJAP, pCIA-P, pVAX1-wapA), recombinant protein (rPAc, KFD2-rPAc), nanoparticle-adjuvanted (ZIF-8@PAc, chitosan/liposome NPs), live-vector (Salmonella), and passive immunization (anti-CatS-IgY) (n=17) |
| Comparison | Appropriate controls (e.g., unvaccinated / empty vector / PBS); comparator not precisely pre-defined | Unvaccinated / empty vector / PBS / adjuvant-only or vector control groups (n=17) |
| Outcomes | Vaccine efficacy (reduction in S. mutans colonization, CFU counts, caries lesions/scores) and immunogenicity (salivary IgA, serum IgG antibody responses) | Immunogenicity (serum IgG, salivary/secretory IgA) reported in 16 of 17 studies; caries reduction and S. mutans colonization efficacy reported narratively; pooled caries risk ratio 0.53 (95% CI 0.46 to 0.62), I2 = 0.0% |
| Study designs | Peer-reviewed original preclinical studies using in vivo animal models with appropriate controls, published in English | Preclinical in vivo animal experimental studies plus one transgenic-plant antigen-expression study (n=17) |
| Timing | Not specified | Short-term follow-up (post-immunization weeks to a few months); long-term duration of immunity not assessed |
Search date: August 2025. Databases: PubMed; Scopus; Web of Science; Science Direct
Questions and results
Anticaries vaccine or antibody (DNA, recombinant protein, nanoparticle-adjuvanted, live-vector, plant-based, or passive IgY immunization) targeting S. mutans vs Control (unvaccinated / empty vector / PBS / placebo animals)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Serum IgG antibody response (immunogenicity) Anticaries vaccines elicited increased serum IgG antibody responses across the animal studies (ungraded narrative synthesis; no pooled estimate). Source: Data Extraction 'Immunological Outcomes'; Table 3 (antibody response column); Discussion 'Comparative Analysis of Vaccine Platforms' · same question in other reviews | no estimate extracted | NR | Ungraded |
Salivary / secretory IgA (SIgA) antibody response (immunogenicity) Anticaries vaccines, particularly via mucosal (intranasal) routes, elicited increased salivary/secretory IgA responses in the animal studies (ungraded narrative synthesis; no pooled estimate). Source: Data Extraction 'Immunological Outcomes'; Table 3 (antibody response column); Discussion 'DNA Vaccines' and 'Passive Immunization (IgY)' · same question in other reviews | no estimate extracted | NR | Ungraded |
Streptococcus mutans colonization reduction (narrative; no CFU data reported) Anticaries vaccines produced a sustained reduction in Streptococcus mutans colonization on teeth in animal models (ungraded narrative synthesis; no pooled estimate). Source: Abstract; Conclusions; Discussion 'Overview of Main Findings'; Table 3 (efficacy-proxy column) · same question in other reviews | no estimate extracted | NR | Ungraded |
Dental caries development In preclinical animal models, anticaries vaccines significantly reduced dental caries risk (pooled RR 0.53, 95% CI 0.46 to 0.62; random-effects), but the evidence is ungraded and limited to short-term animal studies. Source: Abstract; Results 'Meta-Analysis'; Figure 3 (forest plot: risk ratios) [figure image not available; pooled RR read from text and JATS] · same question in other reviews | RR 0.53 [0.46, 0.62] | NR | Ungraded |
AMSTAR 2 appraisal
Two independent extractors rated each item. Their ratings are shown side by side because they have not been reconciled yet. The overall rating follows Shea et al. 2017: one critical flaw gives Low, more than one gives Critically Low.
| Item | Extractor A | Extractor B | Agree |
|---|---|---|---|
| 1Research question includes PICO components | Yes | Partial Yes | no |
| 2Protocol established before the reviewcritical | Partial Yes | Partial Yes | yes |
| 3Choice of study designs explained | Yes | No | no |
| 4Comprehensive literature searchcritical | Partial Yes | Partial Yes | yes |
| 5Study selection in duplicate | Yes | Yes | yes |
| 6Data extraction in duplicate | Yes | Yes | yes |
| 7List of excluded studies with reasonscritical | No | No | yes |
| 8Included studies described in detail | Partial Yes | Yes | no |
| 9Risk of bias assessed satisfactorilycritical | RCT: N/A · NRSI: Yes | NRSI: N/A · RCT: Yes | no |
| 10Funding of included studies reported | No | No | yes |
| 11Appropriate meta-analysis methodscritical | RCT: N/A · NRSI: Yes | NRSI: N/A · RCT: Yes | no |
| 12Impact of risk of bias on the pooled results | No | No | yes |
| 13Risk of bias accounted for in interpretationcritical | Yes | Yes | yes |
| 14Heterogeneity explained | Yes | Yes | yes |
| 15Publication bias investigatedcritical | No | Partial Yes | no |
| 16Conflicts of interest reported | Yes | Yes | yes |
| Overall | Critically Low | Low | no |
Included primary studies 9
Open as a trial list| Study | Also included by | Outcomes it informs here | Trial PICO | Results |
|---|---|---|---|---|
| Jiang 2017 matched by author and year (probable) | 2 other reviews | not stated | not extracted yet | not extracted yet |
| Batista 2017 matched by author and year (probable) | this review only | not stated | not extracted yet | not extracted yet |
| Chen 2013 matched by author and year (probable) | this review only | not stated | not extracted yet | not extracted yet |
| de Souza Pereira 2022 matched by author and year (probable) | this review only | not stated | not extracted yet | not extracted yet |
| Liu B 2024 matched by author and year (probable) | this review only | not stated | not extracted yet | not extracted yet |
| Liu C 2008 matched by author and year (probable) | this review only | not stated | not extracted yet | not extracted yet |
| Yan 2016 'Quantity over quality': a voice from the Third World. PMID:17192016 | this review only | not stated | not extracted yet | not extracted yet |
| Yang 2009 matched by author and year (probable) | this review only | not stated | not extracted yet | not extracted yet |
| Zhang 2007 matched by author and year (probable) | this review only | not stated | not extracted yet | not extracted yet |
Overlap with other reviews
Reviews that include the same primary studies are not independent evidence. Shared counts match studies by PMID, DOI or NCT, and otherwise by author and year (a probable match).
| Review | Shared studies | Jaccard |
|---|---|---|
| Dental caries in primary and permanent teeth in children's worldwide, 1995 to 2019: a systematic review and meta-analysis. (2020) | 1 | 0.00 |
| A systematic review and meta-analysis on early-childhood-caries global data. (2024) | 1 | 0.01 |