Non-Cochrane · intervention · PM40911429

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

Oral HealthDental cariesAMSTAR 2: Critically Low / Low (extractors disagree)
Full textEvery question was extracted from the full text, figures and supplements by two independent LLM extractors, disagreements adjudicated. Rows cite where in the review the value comes from.
Questions
4
current version
GRADE rated
0
No studies
0
Included studies
9
linked below
No studies 0 · 0%Ungraded 4 · 100%Very low 0 · 0%Low 0 · 0%Moderate 0 · 0%High 0 · 0%

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

ElementPlanned (methods)Found (results)
PopulationAnimal models (nonhuman primates, rodents) or plant-based/transgenic systems evaluating anticaries vaccines targeting Streptococcus mutans17 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)
InterventionAnticaries vaccines (recombinant, plant-based, or DNA vaccines) targeting S. mutans; adjuvants and antibodies (passive immunization) also eligibleAnticaries 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)
ComparisonAppropriate controls (e.g., unvaccinated / empty vector / PBS); comparator not precisely pre-definedUnvaccinated / empty vector / PBS / adjuvant-only or vector control groups (n=17)
OutcomesVaccine 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 designsPeer-reviewed original preclinical studies using in vivo animal models with appropriate controls, published in EnglishPreclinical in vivo animal experimental studies plus one transgenic-plant antigen-expression study (n=17)
TimingNot specifiedShort-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)

Population: Animal caries models (mice, rats, hamsters) challenged/colonized with Streptococcus mutans; one transgenic-plant antigen-expression system
4 questions
OutcomeEffectEvidenceStatus / 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 extractedNRUngraded
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 extractedNRUngraded
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 extractedNRUngraded
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]NRUngraded

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.

ItemExtractor AExtractor BAgree
1Research question includes PICO componentsYesPartial Yesno
2Protocol established before the reviewcriticalPartial YesPartial Yesyes
3Choice of study designs explainedYesNono
4Comprehensive literature searchcriticalPartial YesPartial Yesyes
5Study selection in duplicateYesYesyes
6Data extraction in duplicateYesYesyes
7List of excluded studies with reasonscriticalNoNoyes
8Included studies described in detailPartial YesYesno
9Risk of bias assessed satisfactorilycriticalRCT: N/A · NRSI: YesNRSI: N/A · RCT: Yesno
10Funding of included studies reportedNoNoyes
11Appropriate meta-analysis methodscriticalRCT: N/A · NRSI: YesNRSI: N/A · RCT: Yesno
12Impact of risk of bias on the pooled resultsNoNoyes
13Risk of bias accounted for in interpretationcriticalYesYesyes
14Heterogeneity explainedYesYesyes
15Publication bias investigatedcriticalNoPartial Yesno
16Conflicts of interest reportedYesYesyes
OverallCritically LowLowno

Included primary studies 9

Open as a trial list
StudyAlso included byOutcomes it informs hereTrial PICOResults
Jiang 2017
matched by author and year (probable)
2 other reviewsnot statednot extracted yetnot extracted yet
Batista 2017
matched by author and year (probable)
this review onlynot statednot extracted yetnot extracted yet
Chen 2013
matched by author and year (probable)
this review onlynot statednot extracted yetnot extracted yet
de Souza Pereira 2022
matched by author and year (probable)
this review onlynot statednot extracted yetnot extracted yet
Liu B 2024
matched by author and year (probable)
this review onlynot statednot extracted yetnot extracted yet
Liu C 2008
matched by author and year (probable)
this review onlynot statednot extracted yetnot extracted yet
Yan 2016
'Quantity over quality': a voice from the Third World.
PMID:17192016
this review onlynot statednot extracted yetnot extracted yet
Yang 2009
matched by author and year (probable)
this review onlynot statednot extracted yetnot extracted yet
Zhang 2007
matched by author and year (probable)
this review onlynot statednot extracted yetnot 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).